Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Recruiting

• Conditions: Chronic Hepatitis D Infection
• Interventions: Drug: Bulevirtide

• Registration Number: NCT05718700
• Lead Sponsor: Gilead Sciences

Brief Summary

The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.

Detailed Description

The study design time perspective is retrospective and prospective for participants who previously participated in MYR-Reg-02 and are currently receiving BLV and prospective for participants who are scheduled to receive BLV.

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study Start: 2023-02-07
• Study First Posted: 2023-02-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bulevirtide (previously participated in Study MYR-Reg-2)	Bulevirtide	Participants who are currently receiving bulevirtide (BLV) according to the approved label and have participated in Study MYR-Reg-02.
Bulevirtide	Bulevirtide	Participants who are scheduled to receive BLV according to the approved label.

Primary Outcome Measures

Name	Time	Method
Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death	Up to 144 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Discontinuations Due to AEs	First dose date up to 144 weeks plus 30 days
Percentage of Participants With Serious Adverse Events	First dose date up to 144 weeks plus 30 days
Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)	First dose date up to 144 weeks plus 30 days
Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic	Up to 144 weeks

Trial Locations

Locations (52)

Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie; 🇦🇹 Graz, Austria

Aö Landeskrankenhaus Hall; 🇦🇹 Hall in Tirol, Austria

Universitätsklinik für Innere Medizin I Innsbruck; 🇦🇹 Innsbruck, Austria

Medizinische Universitat Wien; 🇦🇹 Wien, Austria

Centre Hospitalier Universitaire D'Angers; 🇫🇷 Angers, France

Hôpital Avicenne - APHP; 🇫🇷 Bobigny, France

Hopital Beaujon; 🇫🇷 Clichy, France

Hôpitaux Universitaires Henri Mondor; 🇫🇷 Creteil, France

CHU Grenoble Alpes; 🇫🇷 Grenoble, France

Centre Hospitalier Universitaire De Lille- Hôpital Huriez; 🇫🇷 Lille, France

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