Status:
RECRUITING
Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
German Liver Foundation (DLS)
HepNet Study House, German Liverfoundation
Conditions:
Compensated Liver Disease (Disorder)
Hepatitis D, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Finding biomarkers for stopping bulevirtide treatment of patients with hepatitis delta
Detailed Description
This is a multicenter, prospective, single-arm, discontinuation study in which patients who have been treated with BLV for at least 48 weeks, are intentionally discontinued from the treatment. Curren...
Eligibility Criteria
Inclusion
- Men, women, inter/diverse\* aged ≥ 18 years
- Signed written informed consent from subject
- Chronic hepatitis delta
- Stable and continued NUC treatment of the underlying HBV infection
- Previous interferon treatment must have stopped at least 6 months before the start of BLV monotherapy
- Previous immunosuppressant therapy must have stopped at least 6 months before the start of BLV therapy
- BLV treatment for at least 48 weeks
- HDV-RNA below 100 IU/ml under BLV treatment for at least 24 weeks. Patients should have had at least 2 tests with HDV-RNA below 100 IU/ml plus one test with HDV-RNA below 100 IU/ml+ at screening.
- ALT level below 1.5 fold ULN
Exclusion
- Patients with decompensated liver cirrhosis (transient mild deviations in liver function parameters are acceptable at the discretion of the investigator) or history of decompensated liver cirrhosis (patients with minimal perihepatic ascites could be included at the discretion of the investigator)
- Hepatocellular carcinoma (HCC)
- Thrombocytopenia (platelet count below 90.000/µl)
- Participation in another interventional clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
- Any additional medical reason not to stop BLV
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06603311
Start Date
September 30 2024
End Date
September 30 2026
Last Update
June 8 2025
Active Locations (5)
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1
University Hospital Heidelberg; Department of Internal Medicine IV: Gastroenterology, Hepatology, Infectious Diseases, Poisoning
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
University Hospital Frankfurt; Medical Clinic 1
Frankfurt am Main, Hesse, Germany, 60590
3
Hannover Medical School; Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology
Hanover, Lower Saxony, Germany, 30625
4
Charité - University Hospital Berlin (Campus Virchow-Clinic); Department of Hepatology and Gastroenterology
Berlin, Germany, 13353