Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection
Condition(s) studied
Investigational drug(s) / intervention(s)
Stop Treatment with Bulevertide in patients with compensated liver disease and chronic HDV infection: Stop Treatment with Bulevertide in patients with compensated liver disease and chronic HDV infection who have been treated for at least 48 weeks and reached HDV RNA below 100 IU/ml for at least 24 weeks.
Study summary
Finding biomarkers for stopping bulevirtide treatment of patients with hepatitis delta
Eligibility
Primary outcome measure(s)
- Area under the curve (AUC) of biomarker on HDV-RNA relapse at week 48 — week 48
All primary analysis will be carried out in the FAS. All patients will be categorized into two subgroups based on HDV-RNA relapse (yes/no) at week 48: 1. HDV-RNA relapse: HDV-RNA ≥ 1000 IU/ml at any time point up to week 48 2. No HDV-RNA relapse: HDV-RNA above 1000 IU/ml at all time points up to week 48 For the primary analysis, patients with missing HDV-RNA relapse outcome will be imputed with HDV-RNA relapse. Patients who re-initiated bulevirtide will be analysed as having a HDV-RNA relapse independent of their actual relapse status.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Heidelberg; Department of Internal Medicine IV: Gastroenterology, Hepatology, Infectious Diseases, Poisoning | Heidelberg | Baden-Wurttemberg | |
| University Hospital Frankfurt; Medical Clinic 1 | Frankfurt am Main | Hesse | |
| Hannover Medical School; Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology | Hanover | Lower Saxony | |
| Charité - University Hospital Berlin (Campus Virchow-Clinic); Department of Hepatology and Gastroenterology | Berlin | State of Berlin | |
| Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Division of Gastroenterology and Hepatology | Milan | Italy |
More Hannover Medical School trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06603311 on ClinicalTrials.gov ↗ ← All trials in Italy