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
Karolinska University Hospital
400 participants
Sep 27, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria11
- 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.
- For female* participants:
- Postmenopausal for at least one year, or
- Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or
- Abstinence from heterosexual intercourse throughout the treatment period, or
- Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the treatment period and for 6 months after last dose of the drugs in the study.
- Male participants must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) throughout the treatment period and for 6 months after last dose of the drugs in the study.
- Participants who are willing to give written informed consent
Exclusion Criteria4
- 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.
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Interventions
Hepcludex, 2 mg daily subcutaneous injection
Locations(1)
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NCT06051045