Evaluating Bulevirtide Treatment for Chronic Hepatitis D

Observational Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Patients With Chronic Hepatitis D

This study is testing if a new treatment called Bulevirtide can help people with Chronic Hepatitis D feel better and improve their quality of life.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Karolinska University Hospital (Academic / other)
• Locations: 1 site (Stockholm)
• Trial ID: NCT06051045 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old diagnosed with chronic HBV/HDV co-infection and compensated liver disease.

Not a fit: Patients with decompensated liver disease or those not indicated for Bulevirtide treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights into effective treatment options for patients suffering from Chronic Hepatitis D.

How similar studies have performed: Previous studies have shown promise with Bulevirtide, but this observational approach is necessary to gather more comprehensive data on its efficacy and safety.

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, 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 this trial is running

Stockholm

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

Study contacts

• Study coordinator: Soo Aleman, MD, PhD

Conditions Chronic Hepatitis D