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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

Primary Purpose

Chronic Hepatitis C

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Daclatasvir (BMS-790052)
Sofosbuvir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Mayo Clinic
  • USC - Keck Medical Center
  • Yale University School of Medicine
  • University of Florida
  • Piedmont Transplant
  • Indiana University
  • Ochsner Clinic Foundation
  • Mercy Medical Center, Inc.
  • Mass General
  • University of Massachusetts Memorial Medical Center, University Campus
  • Henry Ford
  • Montefiore Medical Center
  • Weill Cornell Medical College
  • Columbia University Medical Center
  • UNC
  • Carolinas Healthcare Institute
  • University of Pennsylvania
  • Research Specialist of Texas
  • Virginia Commonwealth University
  • Swedish Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 10, 2014
Last Updated
January 28, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02161939
Brief Title
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
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
Study Type
Expanded Access

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Daclatasvir (BMS-790052)
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
USC - Keck Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Piedmont Transplant
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Mercy Medical Center, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Mass General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center, University Campus
City
Worchester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Healthcare Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pennsylvania
City
Philadephia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Specialist of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
URL
http://www.bms.com/clinical_trials/investigator_sponsored_research/Pages/expanded-access-program.aspx
Description
EAP Investigator Requests

Learn more about this 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

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