Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

Sponsor

Gilead Sciences (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT01779518

Collaborator

(none)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-transplant Hepatitis C	Drug: Sofosbuvir Drug: Ribavirin Drug: Pegylated Interferon

Study Design

Study Type:

Expanded Access

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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