Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Finding biomarkers for stopping bulevirtide treatment of patients with hepatitis delta
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Charité - University Hospital Berlin (Campus Virchow-Clinic); Department of Hepatology and Gastroenterology
RECRUITING
Berlin
University Hospital Frankfurt; Medical Clinic 1
RECRUITING
Frankfurt Am Main
Hannover Medical School; Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology
RECRUITING
Hanover
University Hospital Heidelberg; Department of Internal Medicine IV: Gastroenterology, Hepatology, Infectious Diseases, Poisoning
RECRUITING
Heidelberg
Italy
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Division of Gastroenterology and Hepatology
RECRUITING
Milan
Contact Information
Primary
Heiner Wedemeyer, Prof. Dr.
Wedemeyer.heiner@mh-hannover.de
+49 511 532
Backup
Esther Grahl
bul-stop.zks@mh-hannover.de
+4917615327247
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 20
Treatments
Experimental: Adults with compensated liver disease and HDV with prior Bulevirtide treatment
Adults with compensated liver disease who have been treated for chronic HDV infection with bulevirtide (BLV) for at least 48 weeks and reached HDV RNA below 100 IU/ml for at least 24 weeks will finite their BLV treatment. Patients will be followed up for 48 weeks to identify promising biomarkers associated with HDV control after stopping BLV and to evaluate the safety of the novel concept of finite BLV treatment in this group of patients
Related Therapeutic Areas
Sponsors
Collaborators: HepNet Study House, German Liverfoundation, German Liver Foundation (DLS)
Leads: Hannover Medical School