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
NCT ID: NCT01979939
Last Updated: 2015-11-03
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
416 participants
INTERVENTIONAL
2013-12-31
2014-11-30
Brief Summary
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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
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Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A 1: DCV/ASV/BMS-791325 in treatment-naive subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
DCV/ASV/BMS-791325
A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
DCV/ASV/BMS-791325
Interventions
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DCV/ASV/BMS-791325
Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥ 10,000 IU/mL at screening
* Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
* Treatment-experienced subjects are eligible
Exclusion Criteria
* Liver or any other organ transplant
* Current or known history of cancer within 5 years prior to enrollment
* Documented or suspected HCC
* Evidence of decompensated liver
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 Medical Center
Chicago, Illinois, United States
Indiana University Med Center
Indianapolis, Indiana, United States
Digestive Disease Associates, P.A.
Catonsville, Maryland, United States
Johns Hopkins Medical Institutions
Lutherville, Maryland, United States
Henry Ford Health System
Novi, Michigan, United States
Kansas City Care Clinic
Kansas City, Missouri, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
The Gastroenterology Group Of South Jersey
Vineland, New Jersey, United States
Binghamton Gastroenterology Associates
Binghamton, New York, United States
Weill Cornell Medical College
New York, New York, United States
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, United States
James J Peters Vamc
The Bronx, 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
Trial Management Associates, Llc
Wilmington, North Carolina, United States
Digestive Health Specialists, Pa
Winston-Salem, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center, Ctr For Liver Diseases
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Quality Medical Research Pllc
Nashville, Tennessee, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Baylor St. Luke'S Medical Center
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
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Newport News, 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
Fitzroy, Victoria, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Fremantle, Western Australia, Australia
Local Institution
Clayton, , 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
Clichy, , France
Local Institution
Limoges, , France
Local Institution
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Pessac, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Fundacion De Investigacion De Diego
San Juan, , Puerto Rico
Countries
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References
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Poordad F, Sievert W, Mollison L, Bennett M, Tse E, Brau N, Levin J, Sepe T, Lee SS, Angus P, Conway B, Pol S, Boyer N, Bronowicki JP, Jacobson I, Muir AJ, Reddy KR, Tam E, Ortiz-Lasanta G, de Ledinghen V, Sulkowski M, Boparai N, McPhee F, Hughes E, Swenson ES, Yin PD; UNITY-1 Study Group. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015 May 5;313(17):1728-35. doi: 10.1001/jama.2015.3860.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2013-002468-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI443-102
Identifier Type: -
Identifier Source: org_study_id
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