Clinical trial NCT01979939: 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
Official title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
timeFrame: Post-Treatment Week 12
Secondary outcomes:
measure: Proportion of subjects in the experienced cohort with SVR12
timeFrame: Follow up Week 12
measure: Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND
timeFrame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
measure: Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND
timeFrame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24
measure: Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort
timeFrame: Up to post treatment week 4 (±7 days)
measure: Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort
timeFrame: Up to post treatment week 4 (±7 days)
measure: Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort
timeFrame: Up to post treatment week 4 (±7 days)
measure: Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b
timeFrame: Post treatment week 12
measure: Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)
timeFrame: Post treatment week 12
measure: Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis
timeFrame: Post treatment week 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Aurora
country: United States
facility: University Of Colorado Denver & Hospital
state: Colorado
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists Of Georgia
state: Georgia
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Med Center
state: Indiana
city: Catonsville
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Care Clinic
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Vineland
country: United States
facility: The Gastroenterology Group Of South Jersey
state: New Jersey
city: Binghamton
country: United States
facility: Binghamton Gastroenterology Associates
state: New York
city: Bronx
country: United States
facility: James J Peters Vamc
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group Of The Hudson Valley, Pc
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, Pa
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center For Liver Disease
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, Llc
state: North Carolina
city: Winston-salem
country: United States
facility: Digestive Health Specialists, Pa
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital Of The University Of Pennsylvania
state: Pennsylvania
city: Pittsburg
country: United States
facility: University Of Pittsburgh Medical Center, Ctr For Liver Diseases
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Nashville
country: United States
facility: Quality Medical Research Pllc
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor St. Luke'S Medical Center
state: Texas
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
city: Alexandria
country: United States
facility: Mt Vernon Endoscopy Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Newport News
country: United States
facility: Bon Secours St. Mary'S Hospital Of Richmond, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Digestive And Liver Disease Specialists
state: Virginia
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Fremantle
country: Australia
facility: Local Institution
state: Western Australia
city: Clayton
country: Australia
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Clichy
country: France
facility: Local Institution
city: Limoges Cedex
country: France
facility: Local Institution
city: Montpellier
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.