NCT06780579

Brief Summary

The goal of this study is to provide access to bulevirtide (BLV (GS-4438), Hepcludex®) to eligible participants with chronic hepatitis delta virus infection (CHD).

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

First QC Date

January 13, 2025

Last Update Submit

March 18, 2026

Conditions

Chronic Hepatitis Delta Virus Infection

Interventions

BulevirtideDRUG

10 mg BLV will be administered via subcutaneous injection

Also known as: GS-4438, Hepcludex®

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with CHD as confirmed by medical records.
  • Compensated liver disease with liver cirrhosis (defined by biopsy, Fibroscan, or clinically by the treating physician) and Child-Pugh score ≤ 6.
  • Positive HDV RNA test within 6 months of initial EAP request (only applicable to patients who have not received treatment with BLV).

You may not qualify if:

  • Coinfection with hepatitis C virus (HCV) (HCV viremia defined by polymerase chain reaction (PCR)) or uncontrolled HIV infection (CD4 \< 500 cells/mm\^3 and detectable HIV RNA).
  • Current or previous (within last 3 months from screening) decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage.
  • Significant medical diseases or conditions, that might decrease the benefit-risk ratio of participating in this program to an unacceptable level, as determined by the treating physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mageras A, Rodriguez N, Katzenstein C, Lee F, Alpert L, Branch AD, Zhang X, Dieterich DT, Kushner T. Novel Implementation of Hepatitis B to Hepatitis Delta Reflex Testing in a US Healthcare System. Am J Gastroenterol. 2025 Jul 31. doi: 10.14309/ajg.0000000000003688. Online ahead of print.

    PMID: 40736690DERIVED

MeSH Terms

Interventions

bulevirtide

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Last Updated

March 20, 2026

Record last verified: 2026-03