Back to resultsExpanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
Primary Purpose
Post-transplant Hepatitis C
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Sofosbuvir
Ribavirin
Pegylated Interferon
Sponsored by
About this trial
This is an expanded access trial for Post-transplant Hepatitis C focused on measuring HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, Pegylated interferon, Ribavirin, Open Label, Sofosbuvir, Liver transplant, Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections, Antiviral Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Antimetabolites, Molecular Mechanisms of Pharmacological Action
Eligibility Criteria
Inclusion Criteria:
- Age > or = 18 years
- Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
- Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
- Life expectancy of < 12 months if the HCV is left untreated
Exclusion Criteria:
- History of clinically significant drug allergy to nucleoside/nucleotide analogs
- Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
- Unable or unwilling to follow the contraception requirements
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01779518
Brief Title
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
Official Title
An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
Brief Summary
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-transplant Hepatitis C
Keywords
HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, Pegylated interferon, Ribavirin, Open Label, Sofosbuvir, Liver transplant, Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections, Antiviral Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Antimetabolites, Molecular Mechanisms of Pharmacological Action
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi™
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Age > or = 18 years
Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
Life expectancy of < 12 months if the HCV is left untreated
Exclusion Criteria:
History of clinically significant drug allergy to nucleoside/nucleotide analogs
Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
Unable or unwilling to follow the contraception requirements
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
We'll reach out to this number within 24 hrs