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

Hepatitis C Clinical Trial

Official title:

A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973049
• Other study ID #: AI443-113
• Secondary ID: 2013-002458-66
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2013
• Last updated: September 23, 2015
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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, IFNa, pegIFNa), 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:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Drug:
• Daclatasvir

• Asunaprevir

• BMS-791325

• Ribavirin

• Placebo matching Ribavirin

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Clayton	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Greenslopes	Queensland
Australia	Local Institution	Heidelberg	Victoria
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
France	Local Institution	Creteil
France	Local Institution	Marseille Cedex 08
France	Local Institution	Montpellier
France	Local Institution	Nice Cedex 03
France	Local Institution	Paris Cedex
France	Local Institution	Paris Cedex 12
United States	Mt Vernon Endoscopy Center	Alexandria	Virginia
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Asheville Gastroenterology Associates, Pa	Asheville	North Carolina
United States	University Of Colorado Denver & Hospital	Aurora	Colorado
United States	Binghamton Gastroenterology Associates	Binghamton	New York
United States	University Of Chicago	Chicago	Illinois
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Advanced Liver Therapies	Houston	Texas
United States	Indiana University Health	Indianapolis	Indiana
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Kansas City Care Clinic	Kansas City	Missouri
United States	Kansas City Research Institute	Kansas City	Missouri
United States	Scripps Clinic	La Jolla	California
United States	Dean Clinic	Madison	Wisconsin
United States	Gastrointestinal Specialists Of Georgia	Marietta	Georgia
United States	Quality Medical Research Pllc	Nashville	Tennessee
United States	Weill Cornell Medical College	New York	New York
United States	Digestive And Liver Disease Specialists	Norfolk	Virginia
United States	Orlando Immunology Center	Orlando	Florida
United States	Texas Liver Institute	San Antonio	Texas
United States	Medical Associates Research Group	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	Miami Research Associates	South Miami	Florida
United States	Carolinas Center For Liver Disease	Statesville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of treated subjects in each of the experienced arms with SVR12		Post treatment 12 Week	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities		Up to end of treatment (week 12) + 7 days	Yes
Secondary	Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b		Post treatment 12 Week	No
Secondary	Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype)		Post treatment 12 Week	No

External Links

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