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
NCT ID: NCT01973049
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2013-12-31
2014-11-30
Brief Summary
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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
NCT01979939
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
NCT02170727
UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
NCT02123654
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
NCT01257204
Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
NCT02098616
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive)
Triple 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
Daclatasvir
Asunaprevir
BMS-791325
Placebo matching Ribavirin
A2: DCV/ASV/BMS-791325 + RBV (naive)
Triple 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
Daclatasvir
Asunaprevir
BMS-791325
Ribavirin
A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)
Triple 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
Daclatasvir
Asunaprevir
BMS-791325
Placebo matching Ribavirin
A4: DCV/ASV/BMS-791325 + RBV (experienced)
Triple 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
Daclatasvir
Asunaprevir
BMS-791325
Ribavirin
Interventions
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Daclatasvir
Asunaprevir
BMS-791325
Ribavirin
Placebo matching Ribavirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Scripps Clinic
La Jolla, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
Kansas City Care Clinic
Kansas City, Missouri, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Binghamton Gastroenterology Associates
Binghamton, New York, United States
Weill Cornell Medical College
New York, New York, United States
Asheville Gastroenterology Associates, Pa
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Quality Medical Research Pllc
Nashville, Tennessee, United States
Advanced Liver Therapies
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Mt Vernon Endoscopy Center
Alexandria, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Digestive And Liver Disease Specialists
Norfolk, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Darlinghurst, New South Wales, Australia
Local Institution
Greenslopes, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Clayton, Victoria, Australia
Local Institution
Fitzroy, Victoria, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Fremantle, Western Australia, Australia
Local Institution
Calgary, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Créteil, , France
Local Institution
Marseille, , France
Local Institution
Montpellier, , France
Local Institution
Nice, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Countries
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References
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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.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2013-002458-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI443-113
Identifier Type: -
Identifier Source: org_study_id
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