[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-d-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-d-chronic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,74],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639893","phase-1-safety-and-antiviral-activity-of-a-monoclonal-hepatitis-b-antibody-a-phase-1b-open-label-trial-in-individuals-with-chronic-hepatitis-d-infection-100639893",false,"NCT07610772","Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection","Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection (the SAMBA-D Study)","Inclusion Criteria:\n\n* HDV infection confirmed by positive anti-HDV antibody and detectable HDV RNA\n* HBs antibody negative during screening period\n* Both HBeAg positive and negative participants are included\n* Ability and willingness to provide informed consent\n* Participants who can become pregnant must agree to use two methods of contraception:\n* Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant.\n\nExclusion Criteria:\n\n* Child-Turcotte-Pugh \\>9 points\n* Severe clinical hepatic decompensation-such as hepatic encephalopathy or variceal hemorrhage-occurring currently or within the past 12 months.\n* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable)\n* Pregnancy or lactation\n* Any vaccination 2 weeks prior to entry\n* Prior receipt of HepB mAb19 therapy\n* Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness 2 weeks prior to entry\n* Active hepatitis C infection\n* Untreated HIV disease\n* Individuals with HIV receiving antiretroviral therapy who have had a measurement of plasma HIV RNA (viral load) \\>50 copies\u002FmL within the past 6 months are excluded. However, a single viral load measurement between \\>50 and \\\u003C500 copies\u002FmL during this period is acceptable.\n* Participation in another clinical study of an investigational product currently or 12 weeks prior to entry, or expected participation during this study\n\nLaboratory abnormalities in the parameters listed below:\n\n* Alpha fetoprotein \\>100 ng\u002FmL\n* Hemoglobin \\\u003C10 gm\u002FdL (6.21 mmol\u002FL)\n* Platelet count \\\u003C25,000 \u002Fmm3\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\n* ALT ≥ x10 upper limit of normal (ULN)\n\nCurrent, or history of:\n\n* Clinical cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure.\n* Presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., PR interval \\>210 ms (1st degree AV block only if clinical symptoms are present), QT corrected for heart rate using the Fridericia's correction factor \\[QTcF\\] \\> 450 ms for males and QTcF \\>470 ms for females);\n* Chronic liver disease from another cause, ICD, or autoimmune diseases that in the opinion of the investigator would preclude participation\n* History of hematopoietic stem cell transplant or solid organ transplant","ALL","18 Years","70 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Hepatitis D virus (HDV) is a major global health issue, with an estimated 12 million people living with the infection worldwide. HDV infection requires the presence of hepatitis B virus (HBV), as it relies on hepatitis B virus for replication within the liver cells. Treatment options for HDV are limited and cannot cure the infection. The combination of concurrent HBV and HDV increases the risk of developing severe liver disease, including cirrhosis and liver cancer. This risk would significantly decrease if HDV is eliminated or reduced. Consequently, there is a need for the development of new treatment options.\n\nColleagues at Rockefeller University in New York have identified the antibody HepB mAb19, which effectively reduces the amount of circulating HBV antigens. Since HDV depends on HBV to replicate, we will test this antibody as a potential treatment for HDV.\n\nThe trial design is a phase 1b open-label aiming at including 15 study participants with chronic hepatitis D infection. All study participants will receive two or three dosis of the antibody, HepB mAB19, and will be followed for 60 weeks after the first HepB mAb19 infusion.\n\nThis study will evaluate the safety and pharmacokinetics of this antibody, as well as its potential effects on viral levels of HDV RNA and antiviral immune responses in individuals living with chronic HDV infection.",[27,28],"Hepatitis D, Chronic","Hepatitis B Chronic Infection",[30,31],"SAMBA-D","2025-522125-36-00 (EU CT no.)","RECRUITING","2026-05-27",{"date":35,"type":36},"2026-05-28","ACTUAL",{"date":38,"type":36},"2026-04-23",{"date":40,"type":21},"2028-04-01",{"name":42,"class":43},"Aarhus University Hospital","OTHER",2,{"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":57,"conditions":58,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100616728","phase-3-phase-iii-clinical-trial-of-hepalatide-in-patients-with-chronic-hepatitis-d-100616728","NCT07309380","Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D","Double-blinded Placebo-controlled Multi-center Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D","Inclusion Criteria:\n\n* Positive HBsAg or HBV DNA for at least 6 months (diagnosed as chronic hepatitis B), with stable nucleos(t)ide analogue (NA) treatment for ≥3 months prior to screening and documented HBV DNA suppression;\n* Positive anti-HDV antibody (IgG and\u002For IgM) and at least two quantifiable HDV RNA measurements ≥3 months apart, with quantifiable HDV RNA at enrollment;\n* 1×ULN\\\u003C ALT\\\u003C10×ULN；\n* No plan for pregnancy within 2 years; female subjects must not be pregnant or lactating, and all subjects must agree to use effective contraception during treatment and for 3 months after the last dose;\n* No participation in other clinical trials within 3 months prior to screening;\n* Good compliance with the study protocol;\n* Ability to understand and willingness to sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Child-Pugh class C or Child-Pugh score ≥10;\n* Subjects with any of the following conditions:\n\n  1. History of severe decompensated liver disease, including moderate to severe ascites (grade 2 or 3), hepatic encephalopathy, gastrointestinal variceal bleeding, hepatorenal syndrome, etc., with an expected survival of less than 2 years;\n  2. History of severe cardiac disease (including unstable or uncontrolled heart disease within the past 6 months, or New York Heart Association \\[NYHA\\] functional class III-IV);\n  3. Uncontrolled epilepsy, severe psychiatric disorders, or a history of severe psychiatric disorders;\n  4. History of organ transplantation;\n  5. Diabetes mellitus or hypertension that is not adequately controlled;\n  6. Presence of autoimmune diseases, immune-related extrahepatic manifestations (including vasculitis, purpura, polyarteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid diseases, malignancies, or receipt of immunosuppressive therapy;\n  7. Presence of serious underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, or other serious diseases;\n  8. History of alcohol abuse or drug addiction.\n* Total bilirubin \\> 51 μmol\u002FL, or serum albumin \\\u003C 28 g\u002FL, or prothrombin time prolonged by \\> 6 seconds;\n* Creatinine clearance\\\u003C60mL\u002Fmin；\n* Co-infection with hepatitis A, C, or E virus, or HIV infection;\n* Use of interferon within 3 months prior to screening;\n* Positive pregnancy test in female subjects;\n* Abnormal hematology results: white blood cell count (WBC) \\\u003C 3×10\\^9\u002FL, neutrophil count 1.5×10\\^9\u002FL, or platelet count 60×10\\^9\u002FL；\n* Current use of prohibited medications that cannot be discontinued;\n* Use of L47 or Myrcludex B within 3 months prior to screening;\n* Subjects receiving standardized nucleos(t)ide analogue (NA) therapy with a treatment duration of less than 12 weeks;\n* Other significant abnormalities in laboratory tests or auxiliary examinations that, in the opinion of the investigator, make the subject unsuitable for participation in this study.","65 Years",{"count":54,"type":21},150,[56],"PHASE3","This study adopts a multicenter, randomized, double-blind, placebo-parallel controlled design to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D.\n\nA total of 150 subjects are planned to be enrolled. After passing the screening, they will be randomly assigned to the L47 group or the placebo group at a ratio of 2:1, with liver cirrhosis and subjects' regional distribution as stratification factors. The two groups will receive hepratide (2.1 mg\u002Fday) or placebo, respectively. Upon completion of the 48-week double-blind treatment phase, all subjects in each group can enter the open-label treatment follow-up phase, where they may voluntarily choose to receive L47 (2.1 mg\u002Fday) treatment or undergo follow-up observation only, until week 144.\n\nSubjects who discontinue treatment prematurely during the trial may also enter the open-label treatment follow-up phase.\n\nAn interim analysis will be conducted after the subjects complete 24 weeks of trial treatment, with the comprehensive response rate at week 24 as the primary endpoint. The analysis will be performed by an independent statistical team. And the interim analysis results will be reviewed by the Independent Data Monitoring Committee (IDMC) .\n\nAll subjects will complete the 48-week double-blind clinical trial. Throughout the entire study period, the safety of subjects will be closely monitored and evaluated, including the monitoring of adverse events (AEs) and other safety indicators.",[27],[60,61],"hepalatide","L47","NOT_YET_RECRUITING","2025-12-16",{"date":65,"type":36},"2025-12-30",{"date":67,"type":21},"2026-04",{"date":69,"type":21},"2027-08",{"name":71,"class":72},"Shanghai HEP Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100375268","national-cohort-of-patients-co-infected-with-hepatitis-b-and-delta-viruses-100375268","NCT04166266","National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses","HEPDELTA","Inclusion Criteria:\n\n* Age \\> 18 years,\n* Presenting a chronic HDV infection (positive serology),\n* Who gave his written informed consent before any intervention and the day of inclusion at the latest,\n* Affiliated to Health Insurance or to the \"Aide Médicale d'Etat\" (request for exemption pending).\n\nExclusion Criteria:\n\n* Patient participating in another biomedical research with an exclusion period ongoing at inclusion,\n* Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).\n* Patients with predictable difficulties of follow-up according to the investigator.",{"count":82,"type":21},800,"7 Years","OBSERVATIONAL","This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV\u002FHDV co-infection.",[27,87],"Hepatitis B, Chronic",[89,90,91,92],"safety","efficacy","evolution","treatment","2025-02-03",{"date":95,"type":36},"2025-02-05",{"date":97,"type":36},"2020-02-19",{"date":99,"type":21},"2028-06-30",{"name":101,"class":102},"ANRS, Emerging Infectious Diseases","OTHER_GOV",38]