drugset / Trial / NCT01779518

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

NCT01779518

Expanded access Approved for marketing Gilead Sciences

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.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Sofosbuvir Small molecule 400 mg
Background Peginterferon alfa-2a Protein / enzyme biologic
Background Ribavirin Small molecule