UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | November 2014 |
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and
treatment experienced non-cirrhotic subjects
treatment experienced non-cirrhotic subjects
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie,
IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
- Treatment-experienced subjects are eligible
Exclusion Criteria:
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected HCC
- Evidence of decompensated liver
We found this trial at
43
sites
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Indiana University Medical Center Indiana University Health is Indiana
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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