RecruitingNCT06051045

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

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

Sponsor

Karolinska University Hospital

Enrollment

400 participants

Start Date

Sep 27, 2023

Study Type

OBSERVATIONAL

Conditions

Chronic Hepatitis D

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bulevirtide for people with chronic hepatitis d. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBulevirtide

Hepcludex, 2 mg daily subcutaneous injection

Locations(1)

Karolinska University Hospital, Department of Infectious Diseases

Stockholm, Sweden

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NCT06051045

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