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A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C - USA Expanded Access Open
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Expanded access is currently available for this treatment.
https://clinicaltrials.gov/ct2/show/NCT02161939?term=daclatasvir+sofosbuvir&rank=5
Verified June 2014 by Bristol-Myers Squibb
Purpose
The primary objective of this program is to provide Daclatasvir (DCV) for 24 weeks to be given in combination with Sofosbuvir (SOF) to post-liver transplant subjects with chronic hepatitis C recurrence and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to < 12 months, including advanced fibrosis or fibrosing cholestatic hepatitis.This protocol will be opened at specific clinical sites for the treatment of individual subjects for whom there are no other treatment options and will allow for the collection of safety and efficacy data.
EXPANDED ACCESS
A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. One of several Study Types.
For more information on expanded access programs, please visit the FDA Web site at
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm.
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A Multicenter Compassionate Use Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
https://clinicaltrials.gov/ct2/show/NCT02097966?term=daclatasvir+sofosbuvir&rank=4
Expanded access is currently available for this treatment.
Verified April 2014 by Bristol-Myers Squibb
Purpose
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without ribavirin to subjects with chronic hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.
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