Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic HBV/HDV Co-infection — BuleDelta  

Hepatitis B, Chronic Clinical Trial

Official title: Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis B Virus (HBV)/Hepatitis D Virus (HDV) Co-infection With Severe Fibrosis Injuries, or Moderate Fibrosis Injuries Associated With Persistent Increase of ALT

Status Recruiting

Clinical Trial Summary

This is a prospective, multicentric, non comparative study, with a retrospective data collection aiming at evaluating the efficacy and safety of bulevirtide in patients with chronic HBV/HDV co-infection with severe fibrosis injuries, or moderate fibrosis injuries associated with persistent increase of ALT.

Clinical Trial Description

Chronic hepatitis delta represents the most severe form of chronic viral hepatitis.The current treatment of hepatitis delta virus (HDV) infection consists in the use of interferon and is largely unsatisfactory. Bulevirtide is an entry inhibitor which has demonstrated significant virologic and biochemical activity in patients with HDV infection in clinical trials.

The ANRS HDEP01 BuleDelta study is an observational cohort, embedded in the french bulevirtide ATU program.

After their inclusion, patients will be followed according to the ATU protocol during treatment within the cohort ATU and according to the usual recommendations during treatment within the nominative ATU (if needed) and after the end of bulevirtide treatment. The patients included will be followed during 48 weeks after the end of their treatment. ;

Related Conditions & MeSH terms

• Coinfection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis D
• Hepatitis D, Chronic

• NCT number: NCT04166266
• Study type: Observational
• Source: ANRS, Emerging Infectious Diseases
• Contact: COULIBALY Fatoumata
• Phone: +331 44 23 61 10
• Email: fatoumata.coulibaly@anrs.fr
• Status: Recruiting
• Start date: February 19, 2020
• Completion date: September 30, 2027