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Collecting data on the long-term effects of bulevirtide for chronic hepatitis D infection

A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection

Observational Gilead Sciences · NCT05718700

This study is trying to see how well bulevirtide works and its long-term effects for people with chronic hepatitis D who are being treated with it.

Quick facts

Study typeObservational
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Locations53 sites (Graz and 52 other locations)
Trial IDNCT05718700 on ClinicalTrials.gov

What this trial studies

This study aims to gather post-marketing data on patients with chronic hepatitis D virus (HDV) infection who are being treated with bulevirtide. It will evaluate the long-term effects and safety of bulevirtide treatment through both retrospective and prospective approaches. Participants include those who have previously taken part in a related study and those who are about to start treatment with bulevirtide. The study will document patient experiences and outcomes over time.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with chronic hepatitis D virus infection for at least six months and who are either currently receiving or scheduled to receive bulevirtide treatment.

Not a fit: Patients currently enrolled in other clinical treatment studies or those with significant concurrent illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of bulevirtide for patients with chronic hepatitis D.

How similar studies have performed: Other studies on bulevirtide have shown promising results, indicating that this approach is building on existing knowledge rather than being entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Individuals who have been diagnosed with chronic hepatitis D virus (HDV) infection for at least 6 months before study enrollment, confirmed by respective documentation in the individuals' medical records.
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
* Must be willing and able to comply with the visit schedule and study requirements.
* Cohort 1 only: Must have participated in study MYR-Reg-02.
* Cohort 2 only: Individuals scheduled to receive bulevirtide (BLV) according to the approved label or for whom the decision to start treatment with BLV according to the approved label has been made and treatment initiation is planned.

Key Exclusion Criteria:

* Individuals currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent.
* History or current presence of clinically significant illness or any other major medical disorder that may interfere with individual follow-up, assessments, or compliance with the protocol.
* Coinfection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) (Individuals with HCV antibodies can be enrolled if HCV RNA is negative).
* Solid organ transplantation.
* Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or gastrointestinal bleeding (GIB)).
* Presence of hepatocellular carcinoma (HCC) as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to Day 1 for individuals with cirrhosis and within 6 months prior to Day 1 for individuals without cirrhosis.
* Pregnant or breastfeeding females.
* Individuals with a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by a positive polymerase chain reaction test result.
* Known hypersensitivity or contraindication to BLV or formulation excipients.
* Individuals who are committed to an institution by virtue of a court or official order.
* Individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed. This includes persons dependent on the sponsor, investigator, or trial site.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Graz and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Hepatitis D Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.