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Approved For Marketing NCT06780579

Expanded Access for Bulevirtide

Conditions: Chronic Hepatitis Delta Virus Infection

Sex: All
Ages: 18 Years – N/A
Sponsor: Gilead Sciences

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).

Eligibility Criteria

Key Inclusion Criteria: * 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). Key Exclusion Criteria: * 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06780579). StuddyBuddy aggregates publicly available trial information.