[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiamen Amoytop Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":227},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,44,74,103,129,151,175,202],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640722","phase-3-the-efficacy-and-safety-of-inpegsomatropin-injection-in-children-with-turner-syndrome-ts-and-short-stature-100640722",false,"NCT07614152","The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature","Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection Versus Givopegsomatropin Solution Injection in the Treatment of Short Stature in Children With Turner Syndrome.","Inclusion Criteria:\n\n* Prepubertal girls at Tanner stage I, with age ≥ 2 years and \\\u003C 12 years at the time of informed consent signature.\n* With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells).\n* At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).\n* At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.\n* No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.\n* Thyroid hormone replacement therapy (if applicable) received prior to randomization should be maintained on a stable regimen for at least 4 weeks.\n* The legal guardian understands and signs the informed consent form; participants aged ≥ 8 years shall also sign the informed consent form. For participants aged under 8 years who are capable of expressing assent, their assent shall be clearly documented.\n\nExclusion Criteria:\n\n* Subjects with closed epiphyses.\n* Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.\n* Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition.\n* Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.\n* Inhaled glucocorticoids used continuously for more than 2 weeks, or oral\u002Fintravenous glucocorticoids used continuously for more than 1 week within 3 months prior to screening.\n* Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, etc.\n* Abnormal liver and renal function at screening (ALT \\> 2 times the upper limit of normal; Cr \\> upper limit of normal).\n* Subjects with abnormal glucose metabolism, including: a. Diagnosed diabetes mellitus; b. Fasting blood glucose ≥ 6.1 mmol\u002FL on two consecutive measurements; c. Glycated hemoglobin (HbA1c) ≥ 6.5%; d. Impaired glucose tolerance judged by the investigator as unsuitable for participation in this study.\n* Presence of chronic infectious diseases judged by the investigator to interfere with study participation, such as chronic hepatitis B.\n* Subjects with systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases (e.g., aortic dissection, uncontrolled hypertension), psychiatric and psychological disorders.\n* Subjects with severe congenital skeletal dysplasia; or those with scoliosis \\> 20°, significant kyphosis, claudication, or a prior diagnosis of slipped capital femoral epiphysis.\n* Subjects with a prior history of intracranial hypertension.\n* Subjects with a history of malignant tumor or current active malignant tumor, including intracranial tumors.\n* Known hypersensitivity to growth hormone or its excipients.\n* Subjects with celiac disease who have not maintained a gluten-free diet within 12 months prior to screening.\n* Any other conditions deemed inappropriate for enrollment in this clinical trial by the investigator.","FEMALE","2 Years","12 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled. Stratified by age and karyotype, subjects will be randomized at a 1:1 ratio to either the test group or the positive control group with continuous treatment for 52 weeks. The study aims to compare the efficacy and safety of Inpegsomatropin-Injection versus Givopegsomatropin Solution Injection in children with TS-related short stature, so as to provide evidence for the new indication application of the investigational drug.",[27],"Turner Syndrome",[29,30],"Inpegsomatropin Injection","Givopegsomatropin Solution Injection","NOT_YET_RECRUITING","2026-05-28",{"date":34,"type":35},"2026-06-02","ACTUAL",{"date":37,"type":21},"2026-06-15",{"date":39,"type":21},"2030-02-28",{"name":41,"class":42},"Xiamen Amoytop Biotech Co., Ltd.","INDUSTRY",51,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100635370","phase-2-safety-pharmacokinetic-pk-profile-and-efficacy-of-inpegsomatropin-injection-in-adults-with-growth-hormone-deficiency-100635370","NCT07551804","Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency","A Multiple-Dose, Dose-Escalation, Randomized, Double-Blind, Placebo-Controlled Phase Ⅱa Clinical Trial to Evaluate the Safety, Pharmacokinetic (PK) Profile and Preliminary Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency","Inclusion Criteria:\n\n* Male study participants aged ≥ 18 years and \\\u003C 80 years at the time of signing the informed consent form (ICF);\n* Study participants meeting the criteria for adult growth hormone deficiency (AGHD):\n\nPatients with a peak GH level \\\u003C 5 μg\u002FL measured by insulin tolerance test (ITT); OR Patients with an IGF-1 level below -2.0 SDS for age and sex at screening (see Appendix 4);\n\n* No systemic treatment with growth hormone or growth hormone secretagogues within 6 months prior to entering the screening period;\n* For patients with any other pituitary hormone deficiency who are on hormone replacement therapy (HRT) at screening, HRT must have been stable for at least 3 months;\n* Study participants must agree to use reliable contraceptive measures with their spouses from - Study participants fully understand the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in the study, and have signed the informed consent form.\n\nExclusion Criteria:\n\n* Individuals with known or suspected hypersensitivity to the investigational product or its excipients;\n* Patients with severe malnutrition as judged by the investigator, or with a BMI \\\u003C 18.5 kg\u002Fm² at screening;\n* Patients with active malignancy or a history of malignancy; or with thyroid nodules classified as TI-RADS grade ≥ 4a on thyroid ultrasound; or with high-risk or suspected malignant nodules detected on chest CT; or with clinically significant abnormal tumor markers at screening;\n* For patients with a history of pituitary adenoma or other benign intracranial tumors:\n\n  1. Surgical resection of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening;\n  2. Evidence of growth of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening (must be confirmed by two postoperative MRI scans, with the most recent MRI scan performed ≤ 6 months before the screening period);\n* Patients with abnormal liver or renal function at screening (ALT \\> 3×ULN, Cr \\> 1.5×ULN);\n* Patients testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibody (anti-HIV) at screening;\n* Patients with a clinically significant change in body weight within 6 months prior to screening as judged by the investigator, or with a self-reported body weight change of ≥ 10% compared to 6 months before screening;\n* Patients with unstable control of diabetes mellitus within 3 months prior to screening (HbA1c ≥ 7.5% at screening), or with significant adjustment of hypoglycemic medication dose or change in therapeutic drug type, or with severe diabetic complications as judged by the investigator;\n* Patients with cardiac insufficiency classified as NYHA class ≥ III;\n* Patients with a history of acromegaly or gigantism;\n* Patients with mental disability or language impairment that prevents full participation in the trial;\n* Individuals who have participated in any clinical trial of investigational medicinal products (as a trial participant) and received investigational intervention within 3 months prior to screening;\n* Other conditions deemed unsuitable for enrollment by the investigator.","MALE","18 Years","80 Years",{"count":55,"type":21},36,[57],"PHASE2","This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.",[60],"Adult Growth Hormone Deficiency",[29,62,63,64],"Pharmacokinetic","Safety","Adults With Growth Hormone Deficiency","2026-05-22",{"date":67,"type":35},"2026-05-26",{"date":69,"type":21},"2026-05-31",{"date":71,"type":21},"2028-06-30",{"name":41,"class":42},6,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":52,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100637072","phase-1-safety-tolerability-pharmacokinetic-and-pharmacodynamic-characteristics-of-act500-in-participants-with-metabolic-dysfunction-associated-steatotic-liver-disease-complicated-with-chronic-hepatitis-b-100637072","NCT07589400","Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B","A Multicenter, Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease Complicated With Chronic Hepatitis B.","Inclusion Criteria:\n\n* The participant fully understands the purpose, nature, methods of the trial, and the potential adverse reactions, voluntarily agrees to participate in this study, and signs the informed consent form.\n* Male or female participants aged between 18 and 60 years (inclusive) at the time of signing the informed consent form.\n* Liver fat content ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.\n* Liver stiffness measurement (LSM) by FibroScan during the screening period meets 8 kPa ≤ LSM \\\u003C 12 kPa, or liver biopsy results within 6 months prior to screening show stage F2\u002FF3 liver fibrosis.\n* Hepatitis B surface antigen (HBsAg) positive for \\>6 months at screening, or other evidence of chronic hepatitis B (CHB), with HBV DNA \\\u003C 20 IU\u002FmL.\n* Serum alanine aminotransferase (ALT) \\\u003C 5×ULN at screening.\n* Received nucleos(t)ide analog (NAs) therapy for at least 1 year prior to screening and are currently on stable NA therapy (including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, and tenofovir amibufenamide). Stable NAs therapy is defined as receiving the same treatment regimen within 3 months prior to screening.\n* Have at least one of the following metabolic disease risk factors:\n\nBMI ≥24.0 kg\u002Fm\\^2, or waist circumference ≥90 cm (male) and ≥85 cm (female); Prediabetes: fasting blood glucose ≥6.1 mmol\u002FL, or glycated hemoglobin (HbA1c) ≥5.7%; History of type 2 diabetes mellitus; 1.70 mmol\u002FL ≤ fasting serum triglycerides \\\u003C 5.6 mmol\u002FL; Fasting serum high-density lipoprotein cholesterol ≤1.0 mmol\u002FL (male) and ≤1.3 mmol\u002FL (female), or receiving stable-dose lipid-lowering therapy; Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg; or receiving stable-dose antihypertensive therapy with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg.\n\n* Both male and female participants must agree to use adequate contraceptive methods, where:\n\nMale participants: agree to use reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last dose, and have no sperm donation plans; Female participants: women of non-childbearing potential; or women of childbearing potential who are not pregnant or breastfeeding, must have a negative serum pregnancy test result at screening and within 1 day prior to the first dose, agree to use reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last dose, and have no oocyte donation plans.\n\nExclusion Criteria:\n\n* Concurrent other liver diseases, including but not limited to hepatitis C, hepatitis D, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed liver cancer, etc.\n* Participants with a previous or current history of other malignant tumors, liver cirrhosis (including imaging-confirmed or suspected cirrhosis, and liver biopsy-confirmed cirrhosis), or evidence of decompensated liver disease (such as ascites, esophagogastric variceal bleeding, hepatic encephalopathy), or with a history of liver transplantation.\n* Participants with a history or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmia (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n* Participants with persistent and clinically significant medical history of respiratory, nervous, gastrointestinal, immune, hematological or psychiatric diseases, which, in the opinion of the investigator, may impose additional risks on the participant.\n* Participants with type 1 diabetes or poorly controlled type 2 diabetes (fasting blood glucose \\>9 mmol\u002FL within 3 months prior to screening or glycated hemoglobin \\>9.5% at screening), or diabetic patients using hypoglycemic drugs other than metformin and insulin.\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² (calculated by the CKD-EPI formula) at screening, or with a history of severe renal impairment.\n* Known hemoglobinopathy, hemolytic anemia, sickle cell anemia; or hemoglobin \\\u003C115 g\u002FL in female participants and \\\u003C130 g\u002FL in male participants at screening; or any other conditions judged by the investigator to interfere with hemoglobin detection.\n* Any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) \\>2 times the upper limit of normal (ULN), total bilirubin (TBIL) \\>1.5 times the ULN, international normalized ratio (INR) \\>1.3, albumin \\\u003C35 g\u002FL, platelet count \\\u003C125×10⁹\u002FL, and serum triglycerides \\>5.6 mmol\u002FL.\n* Participants with body weight gain or loss \\>5% within 3 months prior to screening, or those receiving diet control, bariatric surgery, or using approved anti-obesity medications for weight loss indications.\n* Participants with a history of major trauma or surgery within 3 months prior to screening, or those scheduled to undergo surgery during the study period.\n* Excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening. Excessive drinking is defined as weekly ethanol intake ≥210 g for males and ≥140 g for females; or with a history of drug abuse\u002Fdependence or drug inhalation\u002Finjection within 1 year prior to screening.\n* Use of drugs with potential therapeutic effects on MASLD\u002FMASH within 3 months prior to screening (e.g., GLP-1 receptor agonists, DPP4 inhibitors, SGLT2 inhibitors, FGF21 analogues, resmetirom, etc.), or drugs that may induce MASLD\u002FMASH (e.g., amiodarone, methotrexate, tetracyclines, tamoxifen, estrogen at doses exceeding hormone replacement therapy, anabolic steroids, valproic acid, and other known hepatotoxic drugs); use of drugs that may affect the efficacy of hepatitis B treatment within 6 months prior to screening (e.g., anti-HBV drugs other than NAs, interferons, systemic immunomodulators, hepatitis B vaccines, etc.), or any other medications deemed by the investigator to interfere with the study.\n* Participation in other clinical drug trials within 6 months prior to screening.\n* Any positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis C virus antibody (HCV RNA test is required if positive, with the value below the quantitative lower limit of the local study center), hepatitis D virus antibody, or treponema pallidum antibody during the screening period.\n* Participants with allergic reactions to excipients of ACT500 or drugs with similar chemical structures to ACT500, or other drug allergies deemed ineligible for study participation by the investigator.\n* Any other conditions that render the participant unsuitable for this study as determined by the investigator, or participants who are unable to complete the trial due to personal reasons after signing the informed consent form (ICF).","ALL","60 Years",{"count":84,"type":21},24,[86],"PHASE1","This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated with chronic hepatitis B (CHB). The trial plans to enroll 24 participants with MASLD complicated with CHB across three dose cohorts initially, each consisting of 8 participants who will receive oral ACT500 tablets once daily.",[89,90],"Metabolic Dysfunction-associated Steatotic Liver Disease","Chronic Hepatitis b",[89,90,92,93],"ACT500","NM6606","2026-05-11",{"date":96,"type":35},"2026-05-15",{"date":98,"type":21},"2026-05-30",{"date":100,"type":21},"2027-06-30",{"name":41,"class":42},4,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":81,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100616742","phase-3-the-efficacy-and-safety-of-inpegsomatropin-injection-in-children-with-short-stature-born-small-for-gestational-age-100616742","NCT07309562","The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age","A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection, s.c Once a Week, Compared With Recombinant Human Growth Hormone (rhGH) Injection in Children With Short Stature Born Small for Gestational Age（SGA）","Inclusion Criteria:\n\n* Prepubertal (Tanner stage I) children: boys aged ≥2 and \\\u003C11 years, and girls aged ≥2 and \\\u003C10 years at screening.\n* Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).\n* Birth weight and\u002For length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1.\n* Gestational age at birth ≥28 weeks.\n* Height at screening below -2 SD for age and sex, according to the reference values in Appendix 2.\n* Body mass index (BMI) between the 5th and 95th percentiles for age and sex, according to the reference values in Appendix 3.\n* Peak GH level ≥10.0 ng\u002FmL in at least one prior GH stimulation test.\n* No prior systemic growth-promoting therapy (used continuously for ≥1 month), including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc.\n* Legal guardian has provided written informed consent. If the participant is ≥8 years old, they must also provide written assent. For participants under 8 years old who are capable of expressing agreement, their assent should be formally documented.\n\nExclusion Criteria:\n\n* Subjects with closed epiphyses.\n* Subjects with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, short stature due to GH receptor deficiency, short stature due to growth plate-related gene abnormalities (e.g., SHOX gene anomalies), growth retardation due to malnutrition, or growth retardation due to hypothyroidism.\n* Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening.\n* Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral\u002Fintravenous corticosteroids for more than 1 consecutive week, within 3 months prior to screening.\n* Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or insulin.\n* Abnormal liver or kidney function at screening (ALT \\> 1.5 times the upper limit of normal \\[ULN\\], Cr \\> ULN).\n* Diagnosis of diabetes mellitus, or two consecutive fasting blood glucose measurements ≥ 6.1 mmol\u002FL prior to randomization.\n* Chronic infectious diseases which, in the investigator's judgment, may affect study participation (e.g., chronic hepatitis B).\n* Systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases, or psychiatric\u002Fpsychological disorders.\n* Congenital skeletal dysplasia, scoliosis exceeding 15°, limping gait, or a prior diagnosis of slipped capital femoral epiphysis.\n* History of intracranial hypertension.\n* Past or current history of malignant tumors, including intracranial tumors.\n* Known allergy to growth hormone or any of its excipients.\n* Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.","11 Years",{"count":112,"type":21},141,[24],"This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.",[116],"Small for Gestational Age",[29,118],"Recombinant Human Growth Hormone Injection","RECRUITING","2026-05-07",{"date":122,"type":35},"2026-05-08",{"date":124,"type":35},"2026-01-20",{"date":126,"type":21},"2028-05-07",{"name":41,"class":42},49,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":81,"minAge":52,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":102},"100628501","phase-1-safety-tolerability-and-pharmacokineticpharmacodynamicpkpd-profile-of-act500-in-metabolic-dysfunction-associated-steatotic-liver-diseasemasld-100628501","NCT07462455","Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic(PK\u002FPD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)","A Multicenter, Open-label, Multiple-dose Escalation Phase Ⅰb Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic Profile of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease","Inclusion Criteria:\n\n* The participant fully understands the purpose, nature, methods, and possible adverse reactions of the study, voluntarily participates in this study, and has signed the informed consent form.\n* Male or female participants aged between 18 and 69 years (inclusive of 18 and 69 years) at the time of signing the informed consent form.\n* Liver fat content (LFC) ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.\n* Liver stiffness measurement (LSM) assessed by FibroScan during the screening period meets the criteria of 8 kPa ≤ LSM ≤ 15 kPa, OR a liver biopsy pathological result of F2\u002FF3 fibrosis within 6 months prior to screening.\n* Serum alanine aminotransferase (ALT) levels meeting 2×ULN ≤ ALT ≤ 5×ULN at screening.\n* Presence of at least one of the following metabolic risk factors:\n\n  1. BMI ≥ 24.0 kg\u002Fm\\^2, or waist circumference ≥ 90 cm (males) and ≥ 85 cm (females);\n  2. Presence of prediabetes: fasting blood glucose ≥ 6.1 mmol\u002FL, or glycated hemoglobin (HbA1c) ≥ 5.7%;\n  3. History of type 2 diabetes mellitus;\n  4. Fasting serum triglycerides (TG) ≥ 1.70 mmol\u002FL but \\\u003C 5.6 mmol\u002FL;\n  5. Fasting serum high-density lipoprotein cholesterol (HDL-C) ≤ 1.0 mmol\u002FL (males) and ≤ 1.3 mmol\u002FL (females), OR currently receiving a stable dose of lipid-lowering medication;\n  6. Systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg, while simultaneously meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg, OR currently receiving a stable dose of antihypertensive medication and meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg.\n* Both male and female participants must agree to use appropriate contraceptive methods, as follows:\n\n  1. For male participants: Agreement to use reliable contraceptive measures and refrain from sperm donation from signing the informed consent form until 3 months after the last dose.\n  2. For female participants: Female participants of non-childbearing potential; OR female participants of childbearing potential who are not pregnant or breastfeeding, have a negative serum pregnancy test at screening and within 1 day prior to the first dose, and agree to use reliable contraceptive measures and refrain from egg donation from signing the informed consent form until 3 months after the last dose.\n\nExclusion Criteria:\n\n* \\[1\\] Combined with other liver diseases, including but not limited to hepatitis B, hepatitis C, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed hepatocellular carcinoma, etc.\n\n  \\[2\\] Have a history of or currently have other malignancies, liver cirrhosis (including confirmed or suspected liver cirrhosis by imaging examination, or liver cirrhosis confirmed by liver biopsy), or have evidence of decompensated liver disease (such as ascites, esophageal and gastric variceal bleeding, or hepatic encephalopathy, etc.), or have a history of liver transplantation.\n\n  \\[3\\] Have a history of or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmias (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, etc.\n\n  \\[4\\] Have a history of persistent, clinically significant respiratory, neurological, gastrointestinal, immunological, hematological, or psychiatric diseases, which, in the investigator's judgment, would pose additional risk to the participant.\n\n  \\[5\\] Have type 1 diabetes or uncontrolled type 2 diabetes (fasting blood glucose \\>9 mmol\u002FL within 3 months prior to screening, or HbA1c \\>9.5% at screening), or are diabetic patients using glucose-lowering medications other than metformin.\n\n  \\[6\\] Have an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² at screening or a history of severe renal impairment.\n\n  \\[7\\] Have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia; or have hemoglobin \\\u003C105 g\u002FL for female participants or \\\u003C115 g\u002FL for male participants at screening; or any other condition known to interfere with hemoglobin measurement as judged by the investigator.\n\n  \\[8\\] Have any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) \\> 2 × upper limit of normal (ULN), serum total bilirubin (TBIL) \\> 1.5 × ULN, or international normalized ratio (INR) \\> 1.3.\n\n  \\[9\\] Have had a body weight change (increase or decrease) of \\>5% within 3 months prior to screening, or have undergone dieting, bariatric surgery, or used medications approved for weight loss indications.\n\n  \\[10\\] Have a history of major trauma or surgery within 3 months prior to screening, or plan to undergo surgery during the study period.\n\n  \\[11\\] Have a history of excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening, defined as a weekly ethanol intake of ≥210 g for males and ≥140 g for females; or have a history of drug abuse\u002Fdependence or a history of illicit drug inhalation\u002Finjection within 1 year prior to screening.\n\n  \\[12\\] Have used medications that may have a therapeutic effect on MASLD\u002FMASH (e.g., GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors, FGF21 analogs, resmetirom, etc.) or medications that may cause MASLD\u002FMASH (e.g., amiodarone, methotrexate, tetracyclines, tamoxifen, estrogens at doses greater than hormone replacement therapy, anabolic steroids, valproic acid, other known hepatotoxic drugs, etc.) within 3 months prior to screening, or other medications that the investigator considers may affect the trial.\n\n  \\[13\\] Have participated in another drug clinical trial within 3 months prior to screening.\n\n  \\[14\\] Have a positive test for any of the following at screening: human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody.\n\n  \\[15\\] Have a known allergy to the excipients of ACT500 or to drugs with a similar chemical structure to ACT500, or have other drug allergies that, in the investigator's judgment, preclude participation in the study.\n\n  \\[16\\] Have any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study, or are unable to participate in the trial due to the participant's own reasons after signing the informed consent form (ICF).","69 Years",{"count":84,"type":21},[86],"This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The trial plans to enroll approximately 24 MASLD participants across four dose cohorts, each consisting of 6 participants who will receive oral ACT500 once daily.",[141],"Metabolic Dysfunction-associated Steatohepatitis",[141,92,93],"2026-03-15",{"date":145,"type":35},"2026-03-17",{"date":147,"type":21},"2026-03-31",{"date":149,"type":21},"2027-04-30",{"name":41,"class":42},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":81,"minAge":158,"maxAge":110,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100587355","phase-3-the-efficacy-and-safety-of-inpegsomatropin-injection-in-children-with-idiopathic-short-stature-100587355","NCT06927310","The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature","A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection, s.c Once a Week, Compared With Recombinant Human Growth Hormone (rhGH) Injection in Children With Idiopathic Short Stature (ISS).","Inclusion Criteria:\n\n* Prepubertal children: boys aged ≥3 years and \\\u003C11 years at screening with testicular volume \\\u003C4 mL; girls aged ≥3 years and \\\u003C10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue.\n* Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).\n* Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1.\n* Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2.\n* Peak GH level ≥10.0 ng\u002Fml in at least one GH stimulation test.\n* No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.\n* The legal guardian understands and signs the informed consent form. If the participants is ≥8 years old, they must also sign the informed consent form. For participants under 8 years old who are able to express their consent, their assent should be clearly documented.\n\nExclusion Criteria:\n\n* Individuals with closed epiphyses;\n* Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, short stature due to SHOX gene abnormalities, growth delay due to malnutrition, growth delay due to hypothyroidism, and other short statures with a clear etiology; genetic testing results must be obtained before randomization to exclude short stature caused by definite genetic abnormalities;\n* Individuals who have participated in any other clinical trial within 3 months prior to screening and have received pharmacological or non-pharmacological interventions;\n* Individuals who received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 consecutive week, within the 3 months prior to screening;\n* Individuals who are currently receiving or require long-term treatment with other therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, insulin, etc.;\n* Individuals with abnormal liver or kidney function at screening (ALT \\> 1.5 times the upper limit of normal, Cr \\> upper limit of normal);\n* Individuals diagnosed with diabetes mellitus, or with fasting blood glucose ≥6.1 mmol\u002FL on two consecutive occasions;\n* Individuals with chronic infectious diseases, such as chronic hepatitis B;\n* Individuals with systemic chronic diseases, such as moderate to severe anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular diseases (e.g., dilated cardiomyopathy, etc.), psychiatric and psychological disorders, or those with congenital anomalies requiring clinical intervention as determined by the investigator;\n* Individuals with congenital skeletal abnormalities, or those with scoliosis exceeding 15°, limping, or a history of slipped capital femoral epiphysis;\n* Individuals with a history of increased intracranial pressure;\n* Individuals with a history of malignancy or currently having active malignancy, including intracranial tumors;\n* Individuals with severe allergic constitutions, or known allergies to growth hormone or its excipients;\n* Individuals with any other disease that the investigator deems may endanger the subject's safety or compromise compliance with the study protocol.","3 Years",{"count":160,"type":21},300,[24],"This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.",[164],"Idiopathic Short Stature",[29,118],"2026-03-10",{"date":168,"type":35},"2026-03-11",{"date":170,"type":35},"2025-04-28",{"date":172,"type":21},"2028-06",{"name":41,"class":42},38,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":182,"sex":81,"minAge":52,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":4},"100624382","phase-1-safety-tolerability-and-pharmacokineticpharmacodynamic-pkpd-profile-of-act100-in-healthy-participants-100624382","NCT07408908","Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic (PK\u002FPD) Profile of ACT100 in Healthy Participants..","A Single-Center, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled, Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic (PK\u002FPD) Profile of ACT100 in Healthy Participants.","Inclusion Criteria:\n\n1. Participants must voluntarily participate and sign the informed consent form after being informed of the entire trial process and the potential adverse reactions of the investigational product.\n2. Healthy male and female participants aged between 18 and 55 years (inclusive) at the time of signing the informed consent form.\n3. Body mass index (BMI) at screening: 18.5 kg\u002Fm\\^2 ≤ BMI \\\u003C 28 kg\u002Fm\\^2; body weight ≥ 50 kg (for males) \u002F ≥ 45 kg (for females).\n4. At screening, physical examination, vital signs, laboratory tests, electrocardiogram (ECG), etc., are all normal or show abnormalities judged by the investigator as having no clinical significance.\n5. Females of childbearing potential and males must agree to use highly effective contraceptive methods (e.g., intrauterine device, condom) from screening until 3 months after administration of the investigational product and have no plan for sperm or egg donation.\n\nExclusion Criteria:\n\n1. History of treatment with any drug targeting the same molecule (BDCA2) as the investigational product.\n2. A 12-lead electrocardiogram (ECG) at screening showing abnormalities considered clinically significant by the investigator (e.g., QTcF \\> 450 ms for males or \\> 470 ms for females).\n3. History of severe diseases of major organ systems, including but not limited to neurological, cardiovascular, hematological, autoimmune, renal, hepatic, gastrointestinal, pulmonary, endocrine, metabolic, or psychiatric disorders.\n4. Presence of severe bacterial or viral infection (e.g., pneumonia, sepsis, herpes zoster), or fungal\u002Fparasitic infection within 2 months prior to screening; or any symptoms of active or suspected infection within 1 week prior to dosing.\n5. Chronic infectious diseases such as chronic hepatitis B or C, AIDS, tuberculosis, etc. Exclusion applies if any of the following tests are positive at screening: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C antibody (HCVAb), Treponema pallidum antibody, Human Immunodeficiency Virus antibody (HIVAb); or if there is evidence of active or latent Mycobacterium tuberculosis infection at screening.\n6. History of primary immunodeficiency, splenectomy, or any other underlying condition deemed by the investigator to confer a high risk of severe infection.\n7. History of severe food or drug allergy, or known allergy to monoclonal antibodies.\n8. Vaccination with a live attenuated vaccine within 1 month prior to screening, or any other vaccination within half a month prior to screening, or plans to receive any vaccine during the study period.\n9. Use of any prescription drugs, over-the-counter medications (including Chinese herbal medicines, health supplements, etc.) within 14 days prior to the first dose of the investigational product, unless deemed by both the investigator and sponsor to have no impact on the study.\n10. History of drug abuse, illicit drug use, or alcohol abuse (history of drug abuse or illicit drug use within the past 5 years; or habitual alcohol intake exceeding 14 units per week within 3 months prior to screening: 1 unit ≈ 285 mL beer, or 25 mL spirits, or 100 mL wine). Participants with a positive alcohol breath test or positive urine drug abuse screening at screening will be excluded.\n11. Heavy smoking (averaging \\>5 cigarettes per day) within 3 months prior to screening, or unwillingness to refrain from smoking during the study period.\n12. Donation or loss of \\>400 mL of blood within 3 months prior to screening, or \\>200 mL within 1 month prior to screening; or receipt of blood transfusion or blood products within 3 months prior to screening.\n13. Participation in another clinical trial involving an investigational drug\u002Ftherapy within 1 month prior to screening, or within 5 half-lives (based on the known half-life of the prior investigational product, the Investigator's Brochure, or the informed consent form, whichever specifies the longer period).\n14. History of blood\u002Fneedle phobia or intolerance to venipuncture, or abnormalities at the potential injection site deemed by the investigator to be unsuitable for subcutaneous administration.\n15. Females who are pregnant or lactating.\n16. Any other condition that, in the judgment of the investigator, makes the participant unsuitable for participation in this study.",true,"55 Years",{"count":185,"type":21},48,[86],"This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profile of ACT100 in healthy participants. A total of 6 dose cohorts are planned, with each cohort enrolling 8 participants (including both male and female participants, where 6 will receive the investigational drug and 2 will receive placebo). The total planned enrollment is 48 healthy participants.",[189,190],"Systemic Lupus Erythematosus","Cutaneous Lupus Erythematosus",[189,190,192,193],"ACT100","Pharmacokinetics and Pharmacodynamics","2026-02-06",{"date":196,"type":35},"2026-02-13",{"date":198,"type":21},"2026-03-06",{"date":200,"type":21},"2027-10-30",{"name":41,"class":42},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":81,"minAge":52,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":5},"100558539","phase-2-peginterferon--2b-injection-for-hydroxyurea-resistant-or-intolerant-et-100558539","NCT06552429","Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET","A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea.","Inclusion Criteria:\n\n* Male or female subjects, aged greater or equal to 18 years old at screening;\n* Subjects diagnosed as high-risk ET according to the World Health Organization (WHO) 2016 criteria：1) who is older than 60 years and JAK2V617F positive at screening, 2) or who previously suffered from disease-related thrombosis or hemorrhage;\n* Subjects who have previously received HU for ET, and the time interval between the last HU dose and the first dose of the study drug should not be less than 7 days;\n* Interferon treatment-naïve, and for those who have previously received interferon the the time interval between the last dose of interferon and randomization should not be less than 1 month;\n* Patients with confirmed hydroxyurea resistance or intolerant, as at least one of the following criteria is met:\n\n  1. Platelet count remain greater than 600×10\\^9 \u002FL after at least 3 months of HU treatment at a dose ≥2g\u002Fd (dose ≥2.5 g\u002Fd if subject weight \\> 80 kg);\n  2. Platelet count greater than 400\\*10\\^9\u002FL while white blood cell (WBC) count lower than 2.5\\*10\\^9\u002FL, or platelet count greater than 400\\*10\\^9 \u002FL while hemoglobin lower than 100 g\u002FL at any dose of HU;\n  3. Presence of HU-related toxicities at any dose of HU: e.g. ulcers in legs, or any unacceptable skin mucosal manifestations or fever;\n* Platelet counts \\> 450\\*10\\^9\u002FL at screening;\n* Neutrophil count ≥1.0\\*10\\^9\u002FL at screening;\n* Haemoglobin ≥11 g\u002FdL at screening for males and 10 g\u002FdL for females at screening;\n* There is no serious function damage in liver and kidney: total bilirubin ≤1.5 upper limit of normal (ULN), alanine aminotransferase≤2.0 ULN, aspartate aminotransferase≤2.0 ULN, prothrombin time is prolonged by less than 4 seconds, Creatinine clearance ≥50 mL\u002Fmin (according to Cockcroft-Gault formula) at screening;\n* Both male and female subjects must agree take an appropriate contraceptive method, including:\n\n  1. Male subjects: must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug.\n  2. Female subjects: Must meet at least one of the following conditions:\n\n  i) Women without childbearing potential; ii) Women of childbearing potential: no pregnant or breastfeed, negative in blood pregnancy test within 4 days prior to the first dosing, and must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug;\n* Subjects understand the objective, characteristic, method and possible adverse reactions of the study, voluntarily participate in this study, and sign informed consent.\n\nExclusion Criteria:\n\n* History of any other myeloproliferative tumors, or evidence of the presence of any other myeloproliferative tumors;\n* Contraindications or hypersensitivities to interferons of any of its excipients;\n* Severe medical conditions or serious comorbidities that the investigators determined could jeopardize the safety or protocol adherence, e.g. New York Heart Association \\[NYHA\\] Class III-IV, congestive heart failure, symptomatic arrhythmias，pulmonary hypertension;\n* History of major organ transplantation;\n* Documented autoimmune disease or history of autoimmune disease at screening, e.g. medication un-controlled thyroid dysfunction, autoimmune hepatitis, idiopathic thrombocytopenic purpura, scleroderma, psoriasis, or any autoimmune arthritis;\n* Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia at screening that, in the investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol;\n* Infection with systemic clinical manifestations at screening, e.g., bacteria, fungi, human immunodeficiency virus, excluding hepatitis B and\u002For C;\n* Evidence of severe retinopathy, e.g., cytomegalovirus retinitis, symptomatic macular degeneration, or clinically significant eye disease, e.g. due to diabetes mellitus or hypertension;\n* Diagnosed clinically significant depression or a history of depression and, in the investigator's opinion, previous suicide attempts or at any risk of suicide at screening;\n* Diagnosed clinically significant neurological disease or a history of clinically significant neurological disease, except for a history of stable cerebral thrombosis or cerebral hemorrhage;\n* History of any malignancy within 5 years (except stage 0 chronic lymphocytic leukemia, basal cell carcinoma, squamous cell carcinoma, and superficial melanoma);\n* A history of alcohol or drug abuse within 1 year;\n* Have used any investigational drug within 4 weeks prior to first dose of investigational drug, or not recovered from the effects of prior investigational drug administration;\n* Other situations that, in the investigator's opinion, not appropriate for inclusion.",{"count":210,"type":21},27,[57],"This is a multicenter, randomized, open-label Phase 2 clinical study. It is aimed to enroll 27 essential thrombocytopenia (ET) patients who are resistant to or intolerant of hydroxyurea(HU). Eligible patients will be randomized to receive either Peginterferon α-2b 135 mcg or Peginterferon α-2b 180 mcg at a ratio of 1:2, and all subjects will go through a target treatment period (Weeks 1 \\~ Week 48), an extension treatment period (Weeks 49 \\~ Week 96) and a follow-up period (Weeks 97 \\~ Week 100). Pharmacokinetics, safety, efficacy will be evaluated.",[214],"Essential Thrombocythemia",[214,216,217,218],"Peginterferon α-2b","hydroxyurea resistant","hydroxyurea intolerant","2025-11-13",{"date":221,"type":35},"2025-11-17",{"date":223,"type":35},"2024-08-29",{"date":225,"type":21},"2027-09",{"name":41,"class":42},""]