[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Huahui Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":138},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,69,96],{"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":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100635043","phase-1-a-phase-ibii-trial-to-evaluate-the-efficacy-and-safety-of-hh-009-for-the-treatment-of-fgf19-positive-advanced-or-unresectable-hcc-100635043",false,"NCT07547553","A Phase Ib\u002FII Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC","A Randomized, Open-Label, Multicenter, Phase Ib\u002FII Registration Trial to Observe and Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HH-009 Injection in FGF19-Positive Participants With Advanced or Unresectable Hepatocellular Carcinoma (HCC) Who Have Experienced Progressive Disease After Prior Systemic Therapy","Inclusion Criteria:\n\n* Voluntary participation in a clinical trial and signed informed consent.\n* Ages 18 to 75 years (inclusive of the boundaries), male or female.\n* Participants with advanced or unresectable HCC confirmed by pathological histology or diagnosed in accordance with the clinical criteria specified in the National Health Commission guidelines, with the following additional requirements:\n\n  * Participants with HCC who have experienced progressive disease after prio systemic therapy;\n  * Tumor tissue IHC testing for FGF19 was positive (confirmed by central laboratory);\n  * Child-Pugh class A or class B (Child-Pugh score ≤7) ;\n  * Barcelona Clinic Liver Cancer (BCLC) stage B or C\n* ECOG score 0 or 1\n* Have at least one measurable lesion according to RECIST v1.1.\n* Life expectancy ≥ 12 weeks.\n* Adequate organ and bone marrow function.\n* Participants with HCV infection, whose HCV-RNA levels are above the lower limit of detection at the study site, are eligible if antiviral therapy is initiated prior to the first dose administration.\n* Participants with hepatitis B virus (HBV) infection must have HBV DNA \\\u003C 104 cps\u002FmL or 2,000 IU\u002FmL.\n* Participants (including partners of the male participants) are willing to use effective contraception from the screening period until 6 months after the last investigational product administration.\n\nExclusion Criteria:\n\n* Participated in another clinical trial of investigational drugs or investigational medical devices within 28 days prior to the first dose; or received anticancer treatment within the past 4 weeks before the first dose, or within five half-lives of the drug (whichever is shorter), including but not limited to chemotherapy, radiotherapy (allowing palliative radiotherapy completed at least two weeks prior to investigational product administration), targeted therapy, immunotherapy, or endocrine therapy; or received traditional Chinese medicine with anticancer indications within one week before the first dose.\n* The previous antitumor treatment-related toxicity has not yet recovered to ≤ grade 1 or baseline level\n* Previously received FGFR inhibitors, including FGFR4 inhibitors and pan-FGFR inhibitors.\n* Undergone major surgery (except biopsy) within 4 weeks prior to the first study dose of the investigational product, or surgical wounds not fully healed.\n* Presence of moderate to large pleural or ascitic effusion accompanied by clinical symptoms, uncontrolled, or requiring repeated drainage.\n* Participants with active or a history of autoimmune diseases that are likely to recur (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disorders, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or participants at high risk (e.g., participants who have undergone organ transplantation and require immunosuppressive therapy).\n* Participants with a known history of other malignancies within 5 years prior to enrollment.\n* Leptomeningeal (meningeal) metastases, active brain metastases\n* Participants with known active tuberculosis or suspected active tuberculosis, or participants with active pneumonia requiring treatment.\n* History of clinically significant cardiovascular and cerebrovascular diseases.\n* Systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose.\n* History of human immunodeficiency virus (HIV) infection, or active infection requiring systemic treatment for more than 7 consecutive days within 14 days prior to the first dose administration.\n* Co-infection with HBV and HCV\n* Blood transfusion, treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, thrombopoietin, or erythropoietin initiated within 2 weeks prior to the first dose.\n* Bile acid-modulating medications that cannot be discontinued within 3 days prior to the first dose or within 5 half-lives of the drug (whichever is longer).\n* History of severe allergic reactions to other therapeutic antibody drugs; or known allergy to multiple substances or suffering from severe allergic diseases.\n* Pregnant or lactating females, or those with a positive blood pregnancy test.\n* Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results, or any other situation considered unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a randomized, open-label, multicenter Phase Ib\u002FII registration trial designed to evaluate the efficacy and safety of HH-009 in patients with FGF19-positive hepatocellular carcinoma (HCC). The study will also assess pharmacokinetics, pharmacodynamics, immunogenicity, and exploratory biomarkers.\n\nApproximately 30 patients with FGF19-positive advanced HCC will be enrolled. Eligible participants will be randomized 1:1 to receive HH-009 at either 20 mg\u002Fkg or 30 mg\u002Fkg Q3W as monotherapy. Treatment will continue until disease progression, unacceptable toxicity, initiation of new anticancer therapy, study withdrawal, completion of two years of treatment, loss to follow-up, death, or other protocol-specified reasons, whichever occurs first.",[28],"Advanced or Unresectable Hepatocellular Carcinoma (HCC)",[30,31],"Hepatocellular Carcinoma","FGF19 positive","RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2026-05-19",{"date":40,"type":21},"2028-10-30",{"name":42,"class":43},"Huahui Health","INDUSTRY",21,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100632872","phase-2-clinical-study-to-evaluate-the-efficacy-and-safety-of-hh-006-in-patients-with-chronic-hepatitis-b-virus-infection-100632872","NCT07519330","Clinical Study to Evaluate the Efficacy and Safety of HH-006 in Patients With Chronic Hepatitis B Virus Infection","Phase II Clinical Study to Evaluate the Efficacy and Safety of Multiple Dosing of HH-006 in Patients With Chronic Hepatitis B Virus Infection","Inclusion Criteria:\n\n* Sex: male or female; Age: 18 to 45 years old (inclusive);\n* Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI): 18 kg\u002Fm² ≤ BMI ≤ 28 kg\u002Fm²;\n* HBsAg and\u002For HBV DNA positivity for more than 6 months (including 6 months), or previous liver biopsy results indicating chronic hepatitis B, or negative for anti-HBc IgM;\n* Virological and liver function indicators at screening:\n\nCohort 1: HBeAg-positive, 2000 IU\u002FmL ≤ HBsAg ≤ 100,000 IU\u002FmL, HBV DNA \\> 105 IU\u002FmL, 2 × upper limit of normal (ULN) ≤ ALT ≤ 8 × ULN; Cohort 2: HBeAg-negative, 100 IU\u002FmL ≤ HBsAg ≤ 3000 IU\u002FmL, 20 IU\u002FmL \\\u003C HBV DNA ≤ 2000 IU\u002FmL, ALT ≤ 5 × ULN; Cohort 3: HBeAg-negative, 100 IU\u002FmL ≤ HBsAg ≤ 3000 IU\u002FmL, HBV DNA ≤ 100 IU\u002FmL, ALT ≤ 2 × ULN;\n\n* Previous antiviral treatment:\n\nCohort 1 and Cohort 2: No interferon antiviral treatment within the past 1 year, and no nucleos(t)ide analogue (NA) treatment within the 6 months prior to screening; Cohort 3: No interferon antiviral treatment within the past 1 year; received only nucleos(t)ide analogue monotherapy for at least one year;\n\n* Fully understand the study content, procedures, and possible adverse reactions, and sign the written informed consent form (ICF);\n* Able to communicate effectively with the investigator and complete the study in accordance with the study requirements;\n* Male subjects who have not undergone sterilization and female subjects who have been postmenopausal for less than two years must agree to take adequate and effective contraceptive measure from screening until the last follow-up visit.\n\nExclusion Criteria:\n\n* Co-infected with hepatitis C, syphilis, or human immunodeficiency virus (HIV);\n* At screening: total bilirubin ≥ 3 × ULN and direct bilirubin (DBil) \\> 1 × ULN; hemoglobin \\\u003C 100 g\u002FL; platelet count \\\u003C 100,000\u002Fmm³ (100 × 109\u002FL); absolute neutrophil count \\\u003C 1,500\u002Fmm³ (1.5 × 109\u002FL); serum albumin \\\u003C 35 g\u002FL; prothrombin time international normalized ratio (INR) \\> 1.3; glycated hemoglobin (HbA1c) ≥ 7%; estimated glomerular filtration rate (eGFR) (MDRD formula) \\\u003C 60 mL\u002Fmin\u002F1.73 m² (Appendix 2 MDRD calculation formula);\n* Clinically significant electrocardiogram (ECG) abnormalities (e.g., QTcF \\> 450 ms in males, \\> 470 ms in females, severe arrhythmias such as torsade de pointes, paroxysmal ventricular tachycardia, symptomatic atrial fibrillation\u002Fflutter requiring emergency treatment, complete atrioventricular block); poorly controlled or refractory hypertension (e.g., systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg after medication use, etc.);\n* Concurrent clinically significant other liver diseases, including but not limited to: moderate or severe fatty liver, alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, drug-induced liver injury, etc.;\n* History of progressive hepatic fibrosis or cirrhosis at any time prior to or during screening;\n* Current or prior history of hepatic decompensation manifestations, including but not limited to: ascites, hepatic encephalopathy, esophageal and gastric variceal bleeding, hepatorenal syndrome, etc.;\n* Previous history of hepatocellular carcinoma, or at screening: serum alpha-fetoprotein (AFP) ≥ 50 ng\u002FmL; or liver ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of possible hepatocellular carcinoma;\n* Concurrent severe diseases or clinical conditions in other systems that, in the investigator's judgment, make the participant unsuitable for inclusion in this study:\n\n  1. Circulatory system diseases: e.g., unstable angina, myocardial infarction, congestive heart failure, etc.;\n  2. Respiratory system diseases: e.g., severe chronic obstructive pulmonary disease, etc.;\n  3. Primary or secondary kidney diseases (e.g., chronic renal decompensation, renal diseases secondary to diabetes, hypertension, vascular diseases, etc.);\n  4. Endocrine system diseases: e.g., poorly controlled diabetes or thyroid diseases, etc.;\n  5. Autoimmune diseases: e.g., systemic lupus erythematosus, primary immune thrombocytopenia, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, autoimmune hemolytic anemia, severe psoriasis, etc.;\n  6. Neuropsychiatric disorders: e.g., epilepsy, schizophrenia, depression, etc.;\n  7. Malignant tumors;\n* Lactating women or those with a positive pregnancy test;\n* Persistent alcohol consumption (average daily intake \\> 40 g alcohol for males, \\> 20 g alcohol for females) or illicit drug abuse within 6 months prior to screening (including the screening period);\n* Participation in any clinical trial of a drug (except for those who did not receive the investigational product) or medical device (except for non-invasive medical devices) within 3 months prior to screening;\n* Major trauma or major surgery within the past three months;\n* History of allergy to HH-003, HH-006, or polysorbate 80;\n* In the investigator's judgment, unsuitability for participation in this study, or close relationship with the study site: e.g., immediate family members of the investigator, or affiliated personnel (e.g., site staff or students).","45 Years",{"count":54,"type":21},45,[25],"Study HH006-202 is designed to assesses the efficacy and safety of HH-006 in adults chronic HBV infection. Eligible participants will receive study treatment for 48 weeks. All treated patients will also undergo a follow-up period after last study drug treatment.",[58],"Chronic Hepatitis B Virus Infection",[60],"chronic hepatitis B virus infection","2026-06-11",{"date":33,"type":36},{"date":64,"type":36},"2026-05-14",{"date":66,"type":21},"2028-03-22",{"name":42,"class":43},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":68},"100631351","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-libevitug-in-participants-with-chronic-hdv-infection-d-clear-study-100631351","NCT07499544","A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)","A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Assess Efficacy and Safety of Libevitug Injection in Participants With Chronic Hepatitis Delta Virus Infection (D-clear Study)","Inclusion Criteria:\n\n* Willing to sign written informed consent;\n* Chronic HDV history with at least 6 months;\n* HDV RNA ≥500 IU\u002FmL at screening;\n* ALT \\>1ULN and \\\u003C10×ULN;\n* Able to communicate well and comply with protocol.\n\nExclusion Criteria:\n\n* Concomitant decompensated cirrhosis;\n* Previous or current HCC or suspicion for HCC;\n* Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV\u002FHBV;\n* Participants with active hepatitis C infection, or HIV infection;\n* Alcohol abuse or drug addiction within 1 year;\n* Participants have participated in other clinical trial within 1 month;\n* Pregnant, lactating women.","12 Years","70 Years",{"count":79,"type":21},160,[81],"PHASE3","This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.",[84],"Chronic Hepatitis D Infection",[86,87],"Hepatitis Delta Virus (HDV)","Viral hepatitis","2026-06-08",{"date":90,"type":36},"2026-06-10",{"date":92,"type":36},"2026-04-22",{"date":94,"type":21},"2030-01-29",{"name":42,"class":43},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":119,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777","NCT07623369","A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 in Patients With Advanced Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.",{"count":104,"type":21},56,[24],"This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[108,109,30,110,111,112,113,114,115,116,117,118],"Solid Tumor","Non-small Cell Lung Cancer","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Endometrial Cancer","Cervical Cancer","Small-cell Lung Cancer","Triple Negative Breast Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[120,121,109,122,30,123,110,124,125,111,112,126,113,114,115,116,127,117,118,128],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","Ovarian Cancer","NOT_YET_RECRUITING","2026-05-29",{"date":132,"type":36},"2026-06-03",{"date":134,"type":21},"2026-06",{"date":136,"type":21},"2028-08",{"name":42,"class":43},""]