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Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Sponsor: Karolinska University Hospital
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
Conditions
Interventions
Bulevirtide
Hepcludex, 2 mg daily subcutaneous injection
Locations (1)
Karolinska University Hospital, Department of Infectious Diseases
Stockholm, Sweden