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NCT02161939 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

Official title:
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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02161939
Other study ID # AI444-257
Secondary ID
Status No longer available
Phase N/A
First received June 10, 2014
Last updated January 28, 2016

Study information
Verified date January 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Daclatasvir (BMS-790052)

• Sofosbuvir

Locations
Country Name City State
United States Piedmont Transplant Atlanta Georgia
United States Mercy Medical Center, Inc. Baltimore Maryland
United States Mass General Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States UNC Chapel Hill North Carolina
United States Carolinas Healthcare Institute Charlotte North Carolina
United States Henry Ford Detroit Michigan
United States University of Florida Gainesville Florida
United States Research Specialist of Texas Houston Texas
United States Indiana University Indianapolis Indiana
United States USC - Keck Medical Center Los Angeles California
United States Yale University School of Medicine New Haven Connecticut
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Weill Cornell Medical College New York New York
United States University of Pennsylvania Philadephia Pennsylvania
United States Mayo Clinic Phoenix Arizona
United States Virginia Commonwealth University Richmond Virginia
United States Swedish Hospital Seattle Washington
United States University of Massachusetts Memorial Medical Center, University Campus Worchester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

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