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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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02161939
Enrollment
Unknown
Registered
2014-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Brief 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

Interventions

DRUGDaclatasvir (BMS-790052)
DRUGSofosbuvir

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Patients chronically infected with Hepatitis C * Subjects who received a liver transplant, have chronic hepatitis C virus (HCV) recurrence and advanced fibrosis (Metavir F3-F4) or fibrosing cholestatic hepatitis * Subjects with decompensated cirrhosis defined by Child-Pugh Class C

Exclusion criteria

* Patients who are \<18 years old * Clinical or pathologic evidence of acute ongoing liver graft rejection * Creatinine clearance (CrCl) ≤30 mL/min (as estimated by Cockcroft and Gault formula) * Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF) * Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026