MedDataX Logo

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

NCT ID: NCT02161939

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Daclatasvir (BMS-790052)

Intervention Type DRUG

Sofosbuvir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Phoenix, Arizona, United States

Site Status

USC - Keck Medical Center

Los Angeles, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Piedmont Transplant

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Mercy Medical Center, Inc.

Baltimore, Maryland, United States

Site Status

Mass General

Boston, Massachusetts, United States

Site Status

University of Massachusetts Memorial Medical Center, University Campus

Worchester, Massachusetts, United States

Site Status

Henry Ford

Detroit, Michigan, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

UNC

Chapel Hill, North Carolina, United States

Site Status

Carolinas Healthcare Institute

Charlotte, North Carolina, United States

Site Status

University of Pennsylvania

Philadephia, Pennsylvania, United States

Site Status

Research Specialist of Texas

Houston, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Swedish Hospital

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/investigator_sponsored_research/Pages/expanded-access-program.aspx

EAP Investigator Requests

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AI444-257

Identifier Type: -

Identifier Source: org_study_id