- ICH GCP
- US Clinical Trials Registry
- Clinical 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
January 28, 2016 updated by: Bristol-Myers Squibb
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
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
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85054
- Mayo Clinic
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California
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Los Angeles, California, United States, 90033
- USC - Keck Medical Center
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University School of Medicine
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Georgia
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Atlanta, Georgia, United States, 30309
- Piedmont Transplant
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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Maryland
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Baltimore, Maryland, United States, 21202
- Mercy Medical Center, Inc.
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Mass General
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Worchester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center, University Campus
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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New York, New York, United States, 10032
- Columbia University Medical Center
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New York, New York, United States, 10021
- Weill Cornell Medical College
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC
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Charlotte, North Carolina, United States, 28204
- Carolinas Healthcare Institute
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Pennsylvania
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Philadephia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, United States, 77030
- Research Specialist of Texas
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Washington
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Seattle, Washington, United States, 98122
- Swedish Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
June 10, 2014
First Submitted That Met QC Criteria
June 11, 2014
First Posted (Estimate)
June 12, 2014
Study Record Updates
Last Update Posted (Estimate)
January 29, 2016
Last Update Submitted That Met QC Criteria
January 28, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
Other Study ID Numbers
- AI444-257
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Bristol-Myers SquibbWithdrawnHepatitis C VirusUnited States
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Bristol-Myers SquibbCompletedHepatitis CChina, Korea, Republic of, Taiwan
-
Bristol-Myers SquibbCompletedHepatitis CUnited States, Australia, France, Japan, Spain, Sweden, Canada, Germany, Mexico, Denmark, Italy, Korea, Republic of, Taiwan, Argentina, Brazil, Ireland, Poland, Puerto Rico, United Kingdom
-
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-
Bristol-Myers SquibbNo longer availableChronic Hepatitis CNetherlands, Austria, Germany, United Kingdom, Sweden