Status:
COMPLETED
Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA
Lead Sponsor:
Center of target therapy
Conditions:
Chronic Hepatitis D
Eligibility:
All Genders
18+ years
Brief Summary
This observational study will be conducted in patients with chronic co-infection with hepatitis B and D viruses, with negative PCR for HDV RNA in peripheral blood and no signs of active liver inflamma...
Detailed Description
The main goal of this study is the following: \- To assess the probability of HDV relapse-free over time after discontinuation of background therapy with bulevirtide in patients with chronic co-infec...
Eligibility Criteria
Inclusion
- Informed consent of the patient to participate in the study, collect and use data
- Age 18 or older
- Background therapy with bulevirtide for at least 48 weeks
- Negative qualitative PCR test for RNA of viral hepatitis D in peripheral blood before inclusion in the study
- No active liver inflammation
- Liver biopsy performed as part of routine practice (no older than 3 weeks before inclusion in the study) or prescribed biopsy to be performed before bulevirtide interruption
Exclusion
- Liver damage not related to viral hepatitis B and D - autoimmune hepatitis, drug or alcohol liver damage, Wilson-Konovalov disease, etc.
- Co-infection with hepatitis C virus
- Patients receiving HBV and HDV therapy not in accordance with standard practice or violations of the Instructions for the medical use of the drug/s
- Moderate/severe renal/liver dysfunction
- Lack of informed consent
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06121427
Start Date
September 1 2023
End Date
February 28 2025
Last Update
April 25 2025
Active Locations (1)
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1
Center of Target Therapy
Moscow, Russia, 125008