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Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05718700
Recruitment Status : Recruiting
First Posted : February 8, 2023
Last Update Posted : April 15, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Hepatitis D Infection Drug: 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 144 Weeks
Official Title: A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection
Actual Study Start Date : February 7, 2023
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: Bulevirtide
Administered via subcutaneous (SC) injections
Other Name: Hepcludex®
Bulevirtide
Participants who are scheduled to receive BLV according to the approved label.
 Drug: Bulevirtide
Administered via subcutaneous (SC) injections
Other Name: Hepcludex®


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage of Participants Who Develop Cirrhosis During The Study Among Participants Who Were Previously Noncirrhotic [ Time Frame: Up to 144 weeks ]
  2. Percentage of Participants With Serious Adverse Events [ Time Frame: First dose date up to 144 weeks plus 30 days ]
  3. Percentage of Participants With Grade 3 or 4 Adverse Events (AEs) [ Time Frame: First dose date up to 144 weeks plus 30 days ]
  4. Percentage of Participants With Discontinuations Due to AEs [ Time Frame: First dose date up to 144 weeks plus 30 days ]

Biospecimen Retention:   Samples With DNA
Blood and urine samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05718700


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05718700    
Other Study ID Numbers: GS-US-589-6206
2022-501901-10 ( Other Identifier: European Medicines Agency )
First Posted: February 8, 2023    Key Record Dates
Last Update Posted: April 15, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis D
Hepatitis D, Chronic
Hepatitis
Hepatitis, Chronic
Disease Attributes
Pathologic Processes
 Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Chronic Disease