AzTrials
AzTrials

Chronic Hepatitis D InfectionNCT05718700

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

An observational study of Chronic Hepatitis D Infection, run by Gilead Sciences at 53 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis D Infection
What is being tested?
Bulevirtide
Type of treatment
Injection or infusion
How many people
170 participants
Where
53 sitesin 6 countries
Study dates
7 Feb 2023to 31 Aug 2026
How long will I take part?
144 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will enroll participants who participated in Study MYR-Reg-02 or are scheduled to receive BLV according to the approved product label and not currently enrolled in a clinical treatment study.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

53 sites in 6 countries.

53 sites in 6 countries

France16 sites

  • Centre Hospitalier Universitaire D'Angers

    Angers, 49933

  • Hôpital Avicenne - APHP

    Bobigny, 93000

  • Hopital Beaujon

    Clichy, 92118

  • Hôpitaux Universitaires Henri Mondor

    Créteil, 94010

  • CHU Grenoble Alpes

    Grenoble, 38043

  • Centre Hospitalier Universitaire De Lille- Hôpital Huriez

    Lille, 59037

  • CHU de Limoges - Hopital Dupuytren

    Limoges, 87042

  • Hôpital de la Croix-Rousse

    Lyon, 69317

  • Hôpital Saint Eloit

    Montpellier, 34295

  • APHP Hôpital Pitié Salpêtrière

    Paris, 75013

  • Centre Hospitalier De Perigueux

    Périgueux, 24019

  • Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre Hospitalier Annecy Genevois

    Pringy, 74374

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033

  • Hôpital Charles-Nicolle - CHU de Rouen

    Rouen, 76000

  • Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31060

Other trials in France

Germany12 sites

  • Leber- und Studienzentrum Checkpoint

    Berlin, 10961

  • Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology

    Berlin, 13353

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

    Bonn, 53127

  • Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie

    Düsseldorf, 40225

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt, 60590

  • Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V

    Giessen, 35392

  • IFI- Institut für interdisziplinäre Medizin

    Hamburg, 20099

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Liver Study Centre Kiel

    Kiel, 24105

  • Klinikum rechts der Isar der Technischen Universität München

    Munich, 81675

  • St Josephs-Hospital Wiesbaden, Med Klinik 2

    Wiesbaden, 65189

Other trials in Germany

Romania11 sites

  • Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases

    Bucharest, 030303

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital

    Bucharest, 11356

  • National Institute of Infectious Diseases "Prof. Dr. Matei Balş"

    Bucharest, 21105

  • Fundeni Clinical Institute

    Bucharest, 22328

  • Fundeni Clinical Institute

    Bucharest

  • Spitalul Clinic Judetean de Urgenta Craiova

    Craiova, 200349

  • GastroMedica SRL

    Iași, 700111

  • Hospital for Infectious Diseases St. Cuvioasa Paraschiva

    Iași, 700116

  • Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe

    Timișoara

  • Emergency County Clinical Hospital "Pius Brînzeu" Timişoara

    Timișoara

Other trials in Romania

Spain7 sites

  • Complejo Hospitalario Torrecárdena

    Almería, 04009

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario La Paz. Paseo de la Castellana 261

    Madrid, 28029

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

Other trials in Spain

Austria4 sites

  • Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie

    Graz, A-8036

  • Aö Landeskrankenhaus Hall

    Hall in Tirol, 6060

  • Universitätsklinik für Innere Medizin I Innsbruck

    Innsbruck, 6020

  • Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

United Kingdom3 sites

  • Barts Health NHS Trust

    London, E1 1FR

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Bulevirtide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BulevirtideDrug

    Also called Hepcludex®

    Administered via subcutaneous (SC) injections

Study groups in NCT05718700
Study groupRoleWhat they receive
Bulevirtide (previously participated in Study MYR-Reg-2)Participants who are currently receiving bulevirtide (BLV) according to the approved label and have participated in Study MYR-Reg-02.
Receives: Drug: Bulevirtide
BulevirtideParticipants who are scheduled to receive BLV according to the approved label.
Receives: Drug: Bulevirtide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death

    Measured: Up to 144 weeks

Secondary outcomes (4)

  1. Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic

    Measured: Up to 144 weeks

  2. Percentage of Participants With Serious Adverse Events

    Measured: First dose date up to 144 weeks plus 30 days

  3. Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)

    Measured: First dose date up to 144 weeks plus 30 days

  4. Percentage of Participants With Discontinuations Due to AEs

    Measured: First dose date up to 144 weeks plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start7 Feb 2023
  3. Primary completion31 Aug 2026
  4. Study completion31 Aug 2026

Why it stopped: Sponsor decision, no safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
170 participants (actual)
Target duration
144 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT05718700
Sponsor's protocol ID
GS-US-589-6206
Other IDs
2022-501901-10
Status last verified
Sep 2026
First submitted
30 Jan 2023
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis D Infection, run by Gilead Sciences at 53 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in France, Germany, Romania, Spain, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision, no safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death (time frame: Up to 144 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05718700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in