Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
This treatment has been approved for sale to the public.
First Posted: January 30, 2013
Last Update Posted: January 16, 2014
Information provided by (Responsible Party):
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.
|Post-transplant Hepatitis C||Drug: Sofosbuvir Drug: Ribavirin Drug: Pegylated Interferon|
|Study Type:||Expanded Access What is 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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Contacts and Locations
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