Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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
Phase
Start date February 19, 2020
Completion date September 30, 2027

See also
  Status Clinical Trial Phase
Completed NCT03272009 - Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects Phase 1
Recruiting NCT01456312 - HBsAg Related Response Guided Therapy Phase 4
Terminated NCT01886300 - An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam N/A
Completed NCT01023230 - A Study to Assess DV-601 in Subjects With Chronic Hepatitis B Phase 1
Completed NCT00962975 - A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies Phase 1
Terminated NCT00460850 - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B. Phase 4
Completed NCT00536263 - PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327) Phase 3
Completed NCT03681132 - The Norwegian Nucleoside Analogue Stop Study Phase 4
Active, not recruiting NCT05473806 - Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes Phase 4
Withdrawn NCT01179594 - A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B. Phase 4
Recruiting NCT05057065 - A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
Completed NCT04439539 - A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection Phase 2
Withdrawn NCT03125213 - A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects Phase 2
Active, not recruiting NCT04782375 - Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B Phase 4
Withdrawn NCT05550519 - A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment Early Phase 1
Completed NCT02693652 - A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine Phase 1/Phase 2
Enrolling by invitation NCT04160897 - Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
Active, not recruiting NCT02588937 - Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients Phase 4
Completed NCT02612506 - Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers Phase 1
Recruiting NCT02327416 - A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study) Phase 3