Actively Recruiting
Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Led by Karolinska University Hospital · Updated on 2023-09-29
400
Participants Needed
1
Research Sites
491 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Diagnosis of chronic HBV/HDV co-infection
- Compensated liver disease (portal hypertension allowed without ongoing hepatic decompensation such as ascites, variceal bleeding, or hepatic encephalopathy)
- Indication for treatment with Bulevirtide or already receiving Bulevirtide treatment
- For female participants: postmenopausal for at least one year, or surgically sterile, or abstinent from heterosexual intercourse during treatment, or willing to use highly effective contraception throughout treatment and for 6 months after last dose
- Male participants must agree to use highly effective contraception throughout treatment and for 6 months after last dose
- Willingness to provide written informed consent
You will not qualify if you...
- Any contraindications to Bulevirtide treatment, including intolerance or hypersensitivity to Bulevirtide or its components
- Pregnant or breastfeeding women
- Patients with expected difficulties in follow-up as assessed by the investigator
- Any other condition that the investigator believes prevents participation in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karolinska University Hospital, Department of Infectious Diseases
Stockholm, Sweden
Actively Recruiting
Research Team
S
Soo Aleman, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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