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
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
2 other identifiers
interventional
202
4 countries
49
Brief Summary
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2013
Shorter than P25 for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
October 31, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedOctober 9, 2015
September 1, 2015
8 months
October 25, 2013
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12)
SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) \< Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)
Post treatment 12 week
Secondary Outcomes (8)
Proportion of treated subjects in each of the experienced arms with SVR12
Post treatment 12 Week
Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND
Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Proportion of subjects in each arm who achieve HCV RNA < LOQ TND
Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)
Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs)
Up to end of treatment (week 12) + 7 days
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
Up to end of treatment (week 12) + 7 days
- +3 more secondary outcomes
Study Arms (4)
A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive)
EXPERIMENTALTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks
A2: DCV/ASV/BMS-791325 + RBV (naive)
EXPERIMENTALTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200mg tablet orally twice a day for 12 weeks
A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)
EXPERIMENTALTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks
A4: DCV/ASV/BMS-791325 + RBV (experienced)
EXPERIMENTALTriple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If \< 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if ≥ 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening
Interventions
Eligibility Criteria
You may qualify if:
- 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Scripps Clinic
La Jolla, California, 92037, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Quest Clinical Research
San Francisco, California, 94115, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, 80045, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, 30060, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Kansas City Care Clinic
Kansas City, Missouri, 64111, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Binghamton Gastroenterology Associates
Binghamton, New York, 13903, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Asheville Gastroenterology Associates, Pa
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18102, United States
Quality Medical Research Pllc
Nashville, Tennessee, 37211, United States
Advanced Liver Therapies
Houston, Texas, 77030, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
Mt Vernon Endoscopy Center
Alexandria, Virginia, 22306, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Digestive And Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
Local Institution
Darlinghurst, New South Wales, 2010, Australia
Local Institution
Greenslopes, Queensland, 4120, Australia
Local Institution
Adelaide, South Australia, 5000, Australia
Local Institution
Clayton, Victoria, 3168, Australia
Local Institution
Fitzroy, Victoria, 3065, Australia
Local Institution
Heidelberg, Victoria, 3084, Australia
Local Institution
Fremantle, Western Australia, 6160, Australia
Local Institution
Calgary, Alberta, T2N 4Z6, Canada
Local Institution
Vancouver, British Columbia, V5Z 1H2, Canada
Local Institution
Vancouver, British Columbia, V6Z 2C7, Canada
Local Institution
Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution
Victoria, British Columbia, V8V 3P9, Canada
Local Institution
Hamilton, Ontario, L8V 1C3, Canada
Local Institution
Toronto, Ontario, M6H 3M1, Canada
Local Institution
Montreal, Quebec, H2L 4P9, Canada
Local Institution
Montreal, Quebec, H2X 2P4, Canada
Local Institution
Montreal, Quebec, H3A 1T1, Canada
Local Institution
Créteil, 94010, France
Local Institution
Marseille, 13285, France
Local Institution
Montpellier, 34000, France
Local Institution
Nice, 06202, France
Local Institution
Paris, 75013, France
Local Institution
Paris, 75571, France
Related Publications (1)
Muir AJ, Poordad F, Lalezari J, Everson G, Dore GJ, Herring R, Sheikh A, Kwo P, Hezode C, Pockros PJ, Tran A, Yozviak J, Reau N, Ramji A, Stuart K, Thompson AJ, Vierling J, Freilich B, Cooper J, Ghesquiere W, Yang R, McPhee F, Hughes EA, Swenson ES, Yin PD. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. JAMA. 2015 May 5;313(17):1736-44. doi: 10.1001/jama.2015.3868.
PMID: 25942724DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2013
First Posted
October 31, 2013
Study Start
December 1, 2013
Primary Completion
August 1, 2014
Study Completion
November 1, 2014
Last Updated
October 9, 2015
Record last verified: 2015-09