Evaluating Bulevirtide Treatment for Chronic Hepatitis D

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the efficacy and safety of Bulevirtide (BLV) treatment in patients with Chronic Hepatitis D (CHD) through prospective follow-up. Participants will receive 2 mg of BLV, with the possibility of additional treatments such as PEG-IFNα-2a and nucleos(t)ide analogues as part of their routine care. The study will also explore biomarkers in various biological samples and evaluate quality of life outcomes. This research is crucial as CHD is a severe and rare disease with limited treatment options.

Why it matters

Who can join: the full rules

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, or already treated with BLV.
5. For female\* participants:

   1. Postmenopausal for at least one year, or
   2. Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or
   3. Abstinence from heterosexual intercourse throughout the treatment period, or
   4. 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.
6. 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.
7. Participants who are willing to give written informed consent

Exclusion Criteria:

1. Any contra-indications to treatment with BLV, including any intolerance or hypersensitivity to the active ingredient or other components of BLV.
2. Pregnant or breast-feeding women.
3. Patients with predictable difficulties of follow-up according to the investigator.
4. Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.

Where it's running

• Karolinska University Hospital, Department of Infectious Diseases
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Soo Aleman, MD, PhD
• Email: soo.aleman@regionstockholm.se
• Phone: +46 72-595 72 25

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.