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

NCT06051045 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-09-29

No results posted yet for this 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.

Conditions

  • Chronic Hepatitis D

Interventions

DRUG

Bulevirtide

Hepcludex, 2 mg daily subcutaneous injection

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2033-03-31
Completion
2033-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051045 on ClinicalTrials.gov