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 | Completed Phase 3

• 2 other identifiers: AI443-1022013-002468-20
• Study Type: interventional
• Target: 416
• Locations: 5 countries
• Sites: 66

Brief Summary

To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12

  SVR12 is defined as HCV ribonucleic acid (RNA) \< limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12

  Post-Treatment Week 12

Secondary Outcomes (9)

• Proportion of subjects in the experienced cohort with SVR12

  Follow up Week 12

• Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND

  On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

• Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND

  On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24

• Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort

  Up to post treatment week 4 (±7 days)

• Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort

  Up to post treatment week 4 (±7 days)

Study Arms (2)

A 1: DCV/ASV/BMS-791325 in treatment-naive subjects

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Drug: DCV/ASV/BMS-791325

A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Drug: DCV/ASV/BMS-791325

Interventions

DCV/ASV/BMS-791325 DRUG

A 1: DCV/ASV/BMS-791325 in treatment-naive subjects; A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects chronically infected with HCV genotype 1
• 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

You may not qualify if:

• Evidence of cirrhosis
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (66)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

University Of Colorado Denver & Hospital

Aurora, Colorado, 80045, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Gastrointestinal Specialists Of Georgia

Marietta, Georgia, 30060, United States

Location

University Of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University Med Center

Indianapolis, Indiana, 46202, United States

Location

Digestive Disease Associates, P.A.

Catonsville, Maryland, 21228, United States

Location

Johns Hopkins Medical Institutions

Lutherville, Maryland, 21093, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

Kansas City Care Clinic

Kansas City, Missouri, 64111, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

The Gastroenterology Group Of South Jersey

Vineland, New Jersey, 08360, United States

Location

Binghamton Gastroenterology Associates

Binghamton, New York, 13903, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Premier Medical Group Of The Hudson Valley, Pc

Poughkeepsie, New York, 12601, United States

Location

James J Peters Vamc

The Bronx, New York, 10468, United States

Location

Asheville Gastroenterology Associates, Pa

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolinas Center For Liver Disease

Statesville, North Carolina, 28677, United States

Location

Trial Management Associates, Llc

Wilmington, North Carolina, 28403, United States

Location

Digestive Health Specialists, Pa

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Options Health Research, Llc

Tulsa, Oklahoma, 74104, United States

Location

Healthcare Research Consultants

Tulsa, Oklahoma, 74135, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18102, United States

Location

Hospital Of The University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University Of Pittsburgh Medical Center, Ctr For Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

University Gastroenterology

Providence, Rhode Island, 02905, United States

Location

Quality Medical Research Pllc

Nashville, Tennessee, 37211, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Baylor St. Luke'S Medical Center

Houston, Texas, 77030, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Mt Vernon Endoscopy Center

Alexandria, Virginia, 22306, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Bon Secours St. Mary'S Hospital Of Richmond, Inc.

Newport News, Virginia, 23602, United States

Location

Digestive And Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

Dean Clinic

Madison, Wisconsin, 53715, United States

Location

Local Institution

Darlinghurst, New South Wales, 2010, Australia

Location

Local Institution

Greenslopes, Queensland, 4120, Australia

Location

Local Institution

Adelaide, South Australia, 5000, Australia

Location

Local Institution

Fitzroy, Victoria, 3065, Australia

Location

Local Institution

Heidelberg, Victoria, 3084, Australia

Location

Local Institution

Fremantle, Western Australia, 6959, Australia

Location

Local Institution

Clayton, Australia

Location

Local Institution

Calgary, Alberta, T2N 4Z6, Canada

Location

Local Institution

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Local Institution

Vancouver, British Columbia, V6Z 2C7, Canada

Location

Local Institution

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Local Institution

Victoria, British Columbia, V8V 3P9, Canada

Location

Local Institution

Hamilton, Ontario, L8V 1C3, Canada

Location

Local Institution

Toronto, Ontario, M6H 3M1, Canada

Location

Local Institution

Montreal, Quebec, H2L 4P9, Canada

Location

Local Institution

Montreal, Quebec, H2X 2P4, Canada

Location

Local Institution

Montreal, Quebec, H3A 1T1, Canada

Location

Local Institution

Clichy, 92110, France

Location

Local Institution

Limoges, 87042, France

Location

Local Institution

Montpellier, 34295, France

Location

Local Institution

Paris, 75679, France

Location

Local Institution

Pessac, 33604, France

Location

Local Institution

Vandœuvre-lès-Nancy, 54511, France

Location

Fundacion De Investigacion De Diego

San Juan, 00927, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 25942723 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 3, 2015

Record last verified: 2015-10

Locations

FR (6); AU (7); CA (10); US (42); PR (1)