drugset / Trial / NCT02161939

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C

NCT02161939 ↗

Expanded access No longer available Bristol-Myers Squibb

Summary

The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to \<12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data

Timeline

Start
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Primary completion
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Completion
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Drugs

EvaluationDrugModalityDoseRoute
Subject Daclatasvir Small molecule — —
Subject Sofosbuvir Small molecule — —