Chronic Hepatitis Delta Virus InfectionNCT06780579
Expanded Access for Bulevirtide
A study testing Bulevirtide in people with Chronic Hepatitis Delta Virus Infection, run by Gilead Sciences.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis Delta Virus Infection
- What is being tested?
- Bulevirtide
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Expanded Access Treatment Protocol for Bulevirtide
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).
- Conditions
- Chronic Hepatitis Delta Virus Infection
- Being tested
- Bulevirtide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulevirtideDrug
Also called GS-4438, Hepcludex®
10 mg BLV will be administered via subcutaneous injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis Delta Virus InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780579
- Sponsor's protocol ID
- GS-US-589-7094
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
Publications
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. 2026 Jul 1;121(7):1650-1658. doi: 10.14309/ajg.0000000000003688. Epub 2025 Jul 31.
PubMed 40736690
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Treatment Protocol for Bulevirtide
- ClinicalTrials.gov ID
- NCT06780579
- Acronym / sponsor ID
- GS-US-589-7094
- Conditions
- Chronic Hepatitis Delta Virus Infection
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BulevirtideAlso: GS-4438, Hepcludex®10 mg BLV will be administered via subcutaneous injection | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 40736690Mageras 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. 2026 Jul 1;121(7):1650-1658. doi: 10.14309/ajg.0000000000003688. Epub 2025 Jul 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Bulevirtide in people with Chronic Hepatitis Delta Virus Infection, run by Gilead Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.