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

NCT01973049 | Completed Phase 3

• 2 other identifiers: AI443-1132013-002458-66
• Study Type: interventional
• Target: 202
• Locations: 4 countries
• Sites: 49

Brief Summary

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

Conditions

Hepatitis C

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

Study Arms (4)

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive)

EXPERIMENTAL

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

Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Placebo matching Ribavirin

A2: DCV/ASV/BMS-791325 + RBV (naive)

EXPERIMENTAL

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

Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Ribavirin

A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)

EXPERIMENTAL

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

Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Placebo matching Ribavirin

A4: DCV/ASV/BMS-791325 + RBV (experienced)

EXPERIMENTAL

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

Drug: Daclatasvir; Drug: Asunaprevir; Drug: BMS-791325; Drug: Ribavirin

Interventions

Daclatasvir DRUG

Also known as: BMS-790052

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive); A2: DCV/ASV/BMS-791325 + RBV (naive); A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced); A4: DCV/ASV/BMS-791325 + RBV (experienced)

Asunaprevir DRUG

Also known as: BMS-650032

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive); A2: DCV/ASV/BMS-791325 + RBV (naive); A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced); A4: DCV/ASV/BMS-791325 + RBV (experienced)

BMS-791325 DRUG

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive); A2: DCV/ASV/BMS-791325 + RBV (naive); A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced); A4: DCV/ASV/BMS-791325 + RBV (experienced)

Ribavirin DRUG

Also known as: Ribasphere®

A2: DCV/ASV/BMS-791325 + RBV (naive); A4: DCV/ASV/BMS-791325 + RBV (experienced)

Placebo matching Ribavirin DRUG

A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive); A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)

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
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (49)

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

Chicago, Illinois, 60637, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, 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

Binghamton Gastroenterology Associates

Binghamton, New York, 13903, United States

Location

Weill Cornell Medical College

New York, New York, 10021, 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

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18102, United States

Location

Quality Medical Research Pllc

Nashville, Tennessee, 37211, United States

Location

Advanced Liver Therapies

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

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

Clayton, Victoria, 3168, Australia

Location

Local Institution

Fitzroy, Victoria, 3065, Australia

Location

Local Institution

Heidelberg, Victoria, 3084, Australia

Location

Local Institution

Fremantle, Western Australia, 6160, 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

Créteil, 94010, France

Location

Local Institution

Marseille, 13285, France

Location

Local Institution

Montpellier, 34000, France

Location

Local Institution

Nice, 06202, France

Location

Local Institution

Paris, 75013, France

Location

Local Institution

Paris, 75571, France

Location

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: 25942724 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvir; asunaprevir; 8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide; Ribavirin

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

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

Locations

FR (6); AU (7); CA (10); US (26)