Expanded Access for Bulevirtide (NCT06780579) | Clinical Trial Compass
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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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.