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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska University Hospital

About this trial

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 criteria

Qualifiers

Age > 18 years

Diagnosis of chronic HBV/HDV co-infection.

Have compensated liver disease (presence of portal hypertension without ongoing hepatic decompensation as ascites, variceal bleeding and hepatic encephalopathy allowed).

Have indication for treatment of BLV, or already treated with BLV.

Disqualifiers

Any contra-indications to treatment with BLV, including any intolerance or hypersensitivity to the active ingredient or other components of BLV.

Pregnant or breast-feeding women.

Patients with predictable difficulties of follow-up according to the investigator.

Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.

Trial design

Treatments tested in this trial

  • Bulevirtide

Treatment groups

No treatment groups listed

Sponsors and collaborators