Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Recruiting
Observational Study
Chronic Hepatitis D
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 400 (estimated)
- Sponsor
- Karolinska University Hospital · Other
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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/signat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age \> 18 years
2. Diagnosis of chronic HBV/HDV co-infection.
3. Have compensated liver disease (presence of portal hypertension without ongoing hepatic decompensation as ascites, variceal bleeding and hepatic encephalopathy allowed).
4. Have indication for treatment of BLV, …
Contacts