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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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.
You may not be if
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
Clareo Health | 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
