Status:
RECRUITING
Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Lead Sponsor:
Karolinska University Hospital
Conditions:
Chronic Hepatitis D
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Chronic hepatitis D (CHD) is considered to be the most severe form of hepatitis. It is a rare disease in European Union countries, with status of an orphan disease. Historically, only pegylated interf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2033
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06051045
Start Date
September 27 2023
End Date
March 1 2033
Last Update
September 29 2023
Active Locations (1)
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1
Karolinska University Hospital, Department of Infectious Diseases
Stockholm, Sweden