UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Gastroenterology, 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 Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without
Ribavirin in treatment naive cirrhotic subjects.
Ribavirin in treatment naive cirrhotic subjects.
Masking is Double blind for RBV: two or more parties are unaware of the intervention
assignment.
assignment.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1
- Subjects with compensated cirrhosis
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie,
IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease,
polymerase inhibitor, etc.)
- Treatment-experienced subjects are eligible including exposure to anti-HCV agents of
a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir
(ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include,
but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B
(NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.
Exclusion Criteria:
- Subjects without cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to screening
- Documented or suspected hepatocellular carcinoma(HCC)
- Evidence of decompensated liver disease including, but not limited to, radiologic
criteria, a history or presence of ascites, bleeding varices, or hepatic
encephalopathy
We found this trial at
27
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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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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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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