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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT01973049
• Date of registration: 25/10/2013
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: 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
• Scientific title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
• Date of first enrolment: December 2013
• Target sample size: 202
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01973049
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Canada, France, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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,
IFNa, pegIFNa), 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: Placebo matching Ribavirin

Drug: Ribavirin

Drug: BMS-791325

Drug: Asunaprevir

Drug: Daclatasvir

Primary Outcome(s)

Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) [Time Frame: Post treatment 12 week]

Secondary Outcome(s)

Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg = 10 g/dL at baseline in each arm within each cohort [Time Frame: Up to end of treatment (week 12) + 7 days]

Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities [Time Frame: Up to end of treatment (week 12) + 7 days]

Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype) [Time Frame: Post treatment 12 Week]

Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND [Time Frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)]

Proportion of treated subjects in each of the experienced arms with SVR12 [Time Frame: Post treatment 12 Week]

Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs) [Time Frame: Up to end of treatment (week 12) + 7 days]

Proportion of subjects in each arm who achieve HCV RNA < LOQ TND [Time Frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)]

Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b [Time Frame: Post treatment 12 Week]

Secondary ID(s)

2013-002458-66

AI443-113

Source(s) of Monetary Support

Please refer to primary and secondary sponsors