Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA

NCT06121427 | Completed

• 1 other identifier: CTT-001
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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 inflammation according to blood chemistry parameters, receiving background therapy with bulevirtide for more than 48 weeks and liver biopsy performed or prescribed to be performed as part of routine practice. After the patient has signed the Informed Consent, a portion of the liver biopsy collected as part of routine practice will be sent to the laboratory for PCR testing for HDV RNA, background therapy with bulevirtide will be interrupted, and the patient will be observed in the clinic in accordance with routine medical practice, but at least once times every 4 weeks, for timely detection of relapse of the hepatitis D and initiation of antiviral therapy. Once a relapse of viral hepatitis D is determined via the PCR HDV RNA, the patient's participation in the study will be terminated. The collected data will be analyzed to assess the probability of relapse-free over time. Separate tests will also be conducted for subgroups of patients based on covariates such as duration of previous background therapy with bulevirtide, duration of HDV suppression, use of any other concomitant antiviral therapy during bulevirtide treatment.

Conditions

Chronic Hepatitis D

Keywords

bulevirtide

Outcome Measures

Primary Outcomes (1)

• Probability of HDV relapse-free over time

  To assess the probability of HDV relapse-free over time discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA

  96 weeks

Secondary Outcomes (5)

• Probability of HDV relapse-free over time and the duration of previous background therapy with boulevertide

  96 weeks

• Probability of HDV relapse-free over time and the duration of the period of HDV suppression

  96 weeks

• Probability of HDV relapse-free over time and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide

  96 weeks

• Relapse-free patients over 96 weeks

  96 weeks

• Results of qualitative PCR HDV RNA in a liver biopsy

  Baseline (At the time of the patient inclusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic co-infection with hepatitis B and D viruses with negative PCR HDV RNA who meet inclusion/exclusion criteria

You may qualify if:

• 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
• No active liver inflammation

You may not qualify if:

• 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

Sponsors & Collaborators

• Center of target therapy: lead

Study Sites (1)

Center of Target Therapy

Moscow, 125008, Russia

Location

MeSH Terms

Conditions

Hepatitis D, Chronic

Condition Hierarchy (Ancestors)

Hepatitis D; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 8, 2023
• Study Start: September 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)