Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
Bulevirtide: Hepcludex, 2 mg daily subcutaneous injection
Study summary
The aim is to assess the efficacy and specific safety in an observational study of patients with Chronic hepatitis D (CHD) with prospective follow-up, with antiviral treatment of 2 mg Bulevirtide (BLV) +/- PEG-IFNα-2a and +/- NA given as part of the patient's routine medical care. Also, explorative endpoints of biomarkers in peripheral blood, saliva, fecal sample and/or intrahepatic markers/signatures, and quality of life outcomes will be assessed.
Eligibility
Primary outcome measure(s)
- Percentage of patients with virological response of Hepatitis D virus (HDV) RNA < Limit of Detection (LoD) at FU 12 months after End of Treatment (EOT). — Continuously, up to 12 months
Measurement of virological response of HDV RNA \< LoD
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Karolinska University Hospital, Department of Infectious Diseases | Stockholm | Sweden | Recruiting |
More Karolinska University Hospital trials in Sweden
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 NCT06051045 on ClinicalTrials.gov ↗ ← All trials in Sweden