[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chongqing Peg-Bio Biopharm Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,70,94],{"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},"100644796","phase-1-a-clinical-study-on-the-safety-and-tolerability-of-pl54-injection-in-adult-patients-with-phenylketonuria-pku-100644796",false,"NCT07672756","A Clinical Study on the Safety and Tolerability of PL54 Injection in Adult Patients With Phenylketonuria (PKU)","A Phase I Multicenter Open-label Dose-escalation Study of Safety, Tolerability, PK\u002FPD and Immunogenicity of Single\u002FMultiple Subcutaneous PL54 Injection in Adult PKU Patients","Key Inclusion Criteria:\n\n* Adult patients aged 18 to 55 years, inclusive, regardless of sex.\n* Subjects with a prior diagnosis of phenylketonuria (PKU) meeting the following criteria:\n\n  * Blood Phe concentration ≥600 µmol\u002FL at screening;\n  * Average blood Phe concentration ≥600 μmol\u002FL within the 12 months prior to screening (with at least two test results available);\n  * Genetic test report confirming the presence of phenylalanine hydroxylase (PAH) gene defects.\n* Ability to maintain dietary stability from 3 days prior to screening through the end of the trial.\n* Subjects (including partners) capable of practicing effective contraception during the trial period, with no plans for conception within 3 months after trial completion.\n* Voluntarily sign the informed consent form and, in the investigator's judgment, able to comply with all study requirements.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to PL54 injection or any of its excipients.\n* Medical conditions or history assessed by the investigator that may increase the risk of severe allergic reactions (e.g., acute exacerbation of allergic asthma, atopic constitution, history of anaphylaxis, etc.).\n* Use of any medication for PKU (including large neutral amino acids) within 14 days prior to study drug administration or within 5 half-lives of the drug (whichever is longer).\n* Use or planned use of any injectable medication containing polyethylene glycol (PEG) (except the investigational drug) within 3 months prior to screening or during the study period, including medroxyprogesterone acetate injection.\n* Prior use of Pegvaliase (PALYNZIQ®).\n* History of any of the following manifestations associated with prior PEG-containing product use: systemic symptoms (e.g., respiratory or gastrointestinal symptoms, hypotension, angioedema, allergic reactions). The investigator will determine eligibility based on the severity of previous symptoms.\n* Clinically significant abnormal vital signs, physical examination, laboratory tests, or other relevant findings at screening, deemed by the investigator to render the subject unsuitable for enrollment.\n* Significant medical history of immunological, cardiovascular, respiratory, gastrointestinal, endocrine, renal, hematological, neurological, psychiatric, or malignant diseases (except basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised with no evidence of recurrence) assessed by the investigator prior to screening.\n* Stable use of immunosuppressants (e.g., cyclosporine, azathioprine) within 4 weeks prior to screening, with inability to discontinue use during the study period.\n* Vaccination within 4 weeks prior to screening or planned vaccination during the study period.\n* Positive serology for Treponema pallidum-specific antibodies, human immunodeficiency virus (HIV) antibodies, hepatitis C virus (HCV) antibodies, or hepatitis B virus (HBV) surface antigen.\n* Serum creatinine ratio \\> 1.5 × upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) \\> 2 × ULN.\n* Pregnant or breastfeeding women.\n* Participation in any investigational drug trial and receipt of an investigational product within 3 months prior to screening.\n* Prior use of any gene therapy for phenylketonuria (including participation in clinical studies).\n* Any other condition deemed by the investigator to preclude participation in the trial.","ALL","18 Years","55 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary objective of this clinical trial is to evaluate the safety and tolerability of single and multiple administrations of PL54 in patients aged 18-55 years. The key questions it aims to answer include:\n\nHow safe and tolerable is PL54 in PKU patients following single and multiple administrations?\n\nResearchers will compare the safety and tolerability profiles between single and multiple dosing regimens to assess PL54.\n\nParticipants will be required to:\n\nPhase Ia (Single Administration):\n\nReceive a single subcutaneous injection of PL54 based on body weight. Undergo a 28-day observation period post-injection. Visit the clinic for assessments on: D1 (administration day), D2, D7, D8, D10, D15, D22, and D29.\n\nPhase Ib (Multiple Administrations):\n\nReceive subcutaneous injections of PL54 every 7 days (4 doses total) based on body weight. Undergo a 35-day observation period after the last injection. Visit the clinic for assessments on: D1 (first administration), D3, D8, D15, D21, D22, D29, D36, D43, and D57\n\nData to be recorded include:\n\nIncidence, severity, seriousness, relationship to PL54 treatment, duration, and outcome of adverse events (AEs).\n\nChange from baseline in blood phenylalanine (Phe) concentration.",[27],"Phenylketonuria (PKU)",[29,30],"Phenylketonuria","PKU","RECRUITING","2026-06-28",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2025-07-20",{"date":39,"type":21},"2027-08-01",{"name":41,"class":42},"Chongqing Peg-Bio Biopharm Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":69},"100627273","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-pn20-in-the-treatment-of-thrombocytopenia-in-patients-with-chronic-liver-disease-undergoing-an-elective-procedure-100627273","NCT07446491","A Study to Evaluate the Safety and Efficacy of PN20 in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure","A Phase Ib\u002FII Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Characteristics of a Single Subcutaneous Injection of Polyethylene Glycolated Thrombopoietin Peptide (PN20) in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure","Inclusion Criteria:\n\n* Age ≥ 18 years, Male or female\n* Diagnosed with chronic liver disease-related thrombocytopenia (baseline platelet count \\\u003C 50 × 10⁹\u002FL), Child-Pugh score A or B;\n* Planned elective invasive procedure or minor surgery within Days 7-15 post-enrollment, excluding laparotomy, thoracotomy, craniotomy, open-heart surgery, organ resection, or partial organ resection (for tissue biopsy and other types of tissue resection, enrollment is permitted if the investigator considers the risk of bleeding and invasiveness to be comparable to or lower than that of the procedures listed in the surgical examples list);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* Women of childbearing potential must have a negative pregnancy test\n* Agree to use reliable contraception through 3 months post-study.\n* Participants must understand the study requirements and provide written informed consent.\n\nExclusion Criteria:\n\n* The following conditions or medical history:\n\n  * Presence of other conditions that may lead to thrombocytopenia;\n  * History of thrombotic or significant cardiovascular events;\n  * Uncontrolled bleeding;\n  * Advanced liver cancer;\n  * Severe comorbidities;\n* Currently using or with a history of the following treatments:\n\n  * Recent major surgery or splenectomy;\n  * Liver transplant;\n  * Recent therapies affecting platelet counts;\n* Significant lab abnormalities;\n* Recent participation in other clinical trials;\n* Known hypersensitivity to the investigational productstudy drug；\n* Active substance abuse;\n* Any condition deemed by the investigator to compromise safety or study integrity.",{"count":52,"type":21},54,[24,54],"PHASE2","The main aim of this clinical trial is to assess the safety and efficacy of a single dose of PN20 in treatment of thrombocytopenia in adult patients with chronic liver disease undergoing an elective procedure. The main questions it aims to answer are:\n\n* How effective is PN20 in treating thrombocytopenia in patients with chronic liver disease?\n* Is PN20 safe in these patients? Participants will\n* Receive a single subcutaneous injections of PN20 or placebo according to weight before an elective procedure,\n* Visit the clinic for assessment.",[57],"Thrombocytopenia Associated With Chronic Liver Disease",[59,60,61],"PN20","Thrombocytopenia","Chronic Liver Disease","2026-02-26",{"date":64,"type":35},"2026-03-03",{"date":66,"type":35},"2025-06-06",{"date":32,"type":21},{"name":41,"class":42},8,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100583727","phase-1-study-of-pn20-in-adult-patients-with-primary-immune-thrombocytopenia-itp-100583727","NCT06880081","Study of PN20 in Adult Patients With Primary Immune Thrombocytopenia (ITP)","A Phase 1b, Open-label, Single-arm, Dose-escalation Study of PN20 in Patients With Primary Immune Thrombocytopenia (ITP)","Key Inclusion Criteria:\n\n1. Aged between 18 and 65 years (inclusive), male or female;\n2. Diagnosed with primary immune thrombocytopenia (ITP) and have a disease course of more than 6 months;\n3. Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP (such as glucocorticoids, immunoglobulin) and have failed to respond or relapsed after treatment;\n4. During screening period, the mean of two platelet counts must be \\\u003C 30 × 10\\^9\u002FL, with none \\>35 × 10\\^9\u002FL;\n5. Fully understand and are able to comply with the requirements of the protocol, voluntarily participate and sign the informed consent form.\n\nKey Exclusion Criteria:\n\n1. History of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.\n2. Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.\n3. Diagnosed with arterial thrombotic disease (such as cerebral thrombosis, transient ischemic attack, myocardial infarction, peripheral arterial disease, etc.); Patients with a history or complications of venous thrombosis (such as deep vein thrombosis, pulmonary embolism); or patients who are using anticoagulants or antiplatelet drugs at the beginning of screening.\n4. Subjects who have used romiplostim or its analogs in the past and have not responded.\n5. Subjects who have used eltrombopag, haitubopag, avatubopag, recombinant human thrombopoietin (rhTPO), or other drugs with c-MPl stimulating effects within the 4 weeks prior to signing the ICF.\n6. Received any anti-malignancy agents (e.g., cyclophosphamide, mercaptopurine, vincristine, vinblastine, interferon-alfa) within 8 weeks prior to signing the ICF.\n7. Less than 4 weeks since end of any clinical trials about therapeutic drug or device prior to signing the ICF.\n8. Laboratory abnormalities with clinical significance at screening visit.\n9. In the opinions of investigators, the patients are not suitable for participation in this trial.","65 Years",{"count":79,"type":21},12,[24],"The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with primary immune thrombocytopenia (ITP). The main questions it aims to answer are:\n\n* Is PN20 safe in these patients?\n* Could these patients potentially benefit from PN20 treatment?\n\nParticipants will\n\n* Receive one subcutaneous injection of PN20 according to weight;\n* Visit the clinic for assessment.",[83],"Primary Immune Thrombocytopenia (ITP)",[83,85,59],"thrombopoietin receptor agonist",{"date":87,"type":35},"2026-03-02",{"date":89,"type":35},"2025-03-07",{"date":91,"type":21},"2026-04-28",{"name":41,"class":42},5,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":69},"100555476","phase-3-efficacy-and-safety-of-pj009-in-patients-with-short-bowel-syndrome-requiring-parenteral-nutrition-100555476","NCT06512584","Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition","Inclusion Criteria:\n\n1. Male and female aged ≥ 14 years;\n2. SBS patients dependent on PN\u002FIV support for at least 6 consecutive months due to major intestinal resection;\n3. At least 3 PN\u002FIV support sessions per week are required 1 week before screening or 2 weeks before baseline;\n4. Be on stable PN\u002FIV support for at least 4 consecutive weeks before administration;\n5. For subjects with a history of Crohn's disease (CD), clinical assessment of remission for at least 12 weeks prior to administration;\n6. Be able to understand and provide signed informed consent, for those under 18 years old, the guardian should also sign the informed consent;\n7. Be able to complete experiments in accordance with the protocol.\n\nExclusion Criteria:\n\n1. Have used teduglutide in the past or may be allergic to teduglutide or its components;\n2. Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening;\n3. Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening;\n4. With active Crohn's disease or those who need to change biological therapy within 6 months before screening;\n5. With active inflammatory bowel disease (IBD) or IBD patients who have received immunosuppressant therapy changes in the past 3 months;\n6. With unstable absorption due to cystic fibrosis, untreated megacolon disease or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);\n7. With clinically obvious intestinal obstruction or active stenosis within 6 months before screening;\n8. Have undergone major gastrointestinal surgical intervention within 3 months before screening, such as continuous transverse enteroplasty or other intestinal lengthening surgery (esophageal intubation or endoscopic surgery is allowed);\n9. Severe active, uncontrolled, untreated systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system diseases, etc.);\n10. Have malignant tumors within 5 years before screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery);\n11. With severe liver function impairment:\n\n    1. Total bilirubin ≥ 2.0 × upper limit of normal (ULN); for patients with Gilbert's syndrome, direct bilirubin ≥ 2.0 × ULN;\n    2. Aspartate transaminase (AST) ≥ 5.0 × ULN, alanine transaminase (ALT) ≥5.0 × ULN;\n12. With renal function impairment:\n\n    1. Serum creatinine ≥2.0 × ULN;\n    2. Creatinine clearance \\\u003C 60 ml\u002Fmin (calculated according to the Cockcroft-Gault formula, see Appendix 3 for details);\n13. Pancreatic abnormalities:\n\n    1. Serum amylase ≥ 2.0 × ULN;\n    2. Serum lipase ≥ 2.0 × ULN;\n14. More than 4 SBS or PN-related hospitalizations (such as catheter sepsis, intestinal obstruction, severe water and electrolyte disorders) within 12 months before screening;\n15. Unplanned hospitalization within 30 days before screening;\n16. Pregnant or lactating women, women or men who have fertility plans or do not agree to take effective contraceptive measures during the trial;\n17. Participated in any clinical trial (excluding antibody treatment-related clinical trials) within 30 days before screening or participated in any antibody treatment-related clinical trials within 3 months before screening;\n18. Other condition the investigator believes would be unsuitable for participation in this clinical study.","14 Years",{"count":103,"type":21},72,[105],"PHASE3","The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition. The main questions it aims to answer are:\n\n* How effective is PJ009 in treating short bowel syndrome?\n* Is PJ009 safe in these patients? Researchers will compare PJ009 to a placebo (a look-alike substance that contains no drug) to see if PJ009 works to treat SBS.\n\nParticipants will\n\n* Receive daily subcutaneous injections of PJ009 or placebo according to weight for 24 weeks, and then the participants receive placebo will be switched to receive PJ009 for another 12 weeks, while participants receive PJ009 continued the same treatment until the end of 36 weeks,\n* Visit the clinic at the end of week 1(w1), w2, w4, w8, w12, w16, w20, w24, w30 and w36 for assessment,\n* Keep a diary of the amount of their parenteral nutrition\u002F intravenous fluids (PN\u002FIV), enteral nutrition and urine volume.",[108],"Short Bowel Syndrome",[108],{"date":87,"type":35},{"date":112,"type":35},"2024-09-03",{"date":114,"type":21},"2026-04-27",{"name":41,"class":42},""]