Expanded Access for Bulevirtide (NCT06780579) | Clinical Trial Compass
AVAILABLENot Applicable
Expanded Access for Bulevirtide
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.