Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Chronic Hepatitis D Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718700
• Other study ID #: GS-US-589-6206
• Secondary ID: 2022-501901-10
• Status: Recruiting
• Start date: February 7, 2023
• Est. completion date: November 2027

Study information

• Verified date: May 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis D Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis D, Chronic
• Hepatitis, Chronic
• Infections

Intervention

Drug:
• Bulevirtide
Administered via subcutaneous (SC) injections

Locations

Country	Name	City	State
Austria	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
France	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	CHU de Limoges - Hopital Dupuytren	Limoges
France	Hôpital de la Croix-Rousse	Lyon
France	Hôpital Saint Eloit	Montpellier
France	APHP Hôpital Pitié Salpêtrière	Paris
France	Centre Hospitalier De Perigueux	Périgueux
France	Hôpital Haut-Lévêque	Pessac
France	Centre Hospitalier Annecy Genevois	Pringy
France	CHU Rennes - Hôpital Pontchaillou	Rennes
France	Hôpital Charles-Nicolle - CHU de Rouen	Rouen
France	Hôpital Rangueil - CHU de Toulouse	Toulouse
Germany	Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology	Berlin
Germany	Leber- und Studienzentrum Checkpoint	Berlin
Germany	Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I	Bonn
Germany	Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie	Duesseldorf
Germany	Universitätsklinikum Essen	Essen
Germany	Universitätsklinikum Frankfurt Goethe-Universität	Frankfurt
Germany	Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V	Gießen
Germany	IFI- Institut für interdisziplinäre Medizin	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Liver Study Centre Kiel	Kiel
Germany	Klinikum rechts der Isar der Technischen Universität München	Munich
Germany	St Josephs-Hospital Wiesbaden, Med Klinik 2	Wiesbaden
Romania	Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	National Institute of Infectious Diseases "Prof. Dr. Matei Bals"	Bucharest
Romania	Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital	Bucharest
Romania	GastroMedica SRL	Iasi
Romania	Hospital for Infectious Diseases St. Cuvioasa Paraschiva	Iasi
Romania	Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe	Timisoara
Romania	Emergency County Clinical Hospital "Pius Brînzeu" Timisoara	Timisoara
Spain	Complejo Hospitalario Torrecárdena	Almeria
Spain	Hospital Universitari Vall d'Hebrón	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario La Paz. Paseo de la Castellana 261	Madrid
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Austria,  France,  Germany,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic		Up to 144 weeks
Secondary	Percentage of Participants With Serious Adverse Events		First dose date up to 144 weeks plus 30 days
Secondary	Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)		First dose date up to 144 weeks plus 30 days
Secondary	Percentage of Participants With Discontinuations Due to AEs		First dose date up to 144 weeks plus 30 days

External Links

•   Gilead Clinical Trials Website