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RECRUITING
NCT06051045

Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients

Sponsor: Karolinska University Hospital

View on ClinicalTrials.gov

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.

Official title: Observational Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Patients With Chronic Hepatitis D

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2023-09-27

Completion Date

2033-03

Last Updated

2023-09-29

Healthy Volunteers

No

Interventions

DRUG

Bulevirtide

Hepcludex, 2 mg daily subcutaneous injection

Locations (1)

Karolinska University Hospital, Department of Infectious Diseases

Stockholm, Sweden