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).
Brief Title
Expanded Access for Bulevirtide
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-833-445-3230 (GILEAD-0)
Central Contact Email
GileadClinicalTrials@gilead.com
Conditions
CHRONIC HEPATITIS DELTA VIRUS INFECTION
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.
* 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.
Inclusion Criteria
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).
Inclusion/
* 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).
Inclusion/
Gender
All
Gender Based
false
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06780579
Org Class
Industry
Org Full Name
Gilead Sciences
Org Study Id
GS-US-589-7094
Overall Status
Available
Official Title
Expanded Access Treatment Protocol for Bulevirtide
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kristina Chacko
Investigator Email
krchacko@montefiore.org
Investigator Department
Medicine
Investigator Division
Hepatology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Hepatology
MeSH Terms
BULEVIRTIDE