Clinical trial NCT01492426: Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
Official title: A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Detailed description: Allocation: Randomized Stratified

Eligibility criteria: Key Inclusion Criteria:

* Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
* HCV RNA viral load ≥10,000 IU/mL
* No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
* No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
* Body mass index of 18 to 35 kg/m\^2
* Negative for HIV and hepatitis B virus

Key Exclusion Criteria:

* Evidence of decompensated liver disease
* Evidence of medical condition other than HCV contributing to chronic liver disease

Primary outcomes:
measure: Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
timeFrame: Week 12 (Follow-up period)
Secondary outcomes:
measure: Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
timeFrame: Week 4
measure: Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
timeFrame: Week 4, Week 12
measure: Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
timeFrame: Week 12
measure: Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
timeFrame: Week 24 (Follow-up period)
measure: Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
timeFrame: Week 12 (Follow-up period)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Long Beach
country: United States
facility: Va Long Beach Healthcare System
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Medical Center
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists Of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University Of Maryland
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Saint Paul
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: St. Louis
country: United States
facility: Saint Louis University Gastroenterology & Hepatology
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill School Of Med
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Ft. Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: Houston
country: United States
facility: Research Specialists Of Texas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov. Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov De Santa Fe
country: Argentina
facility: Local Institution
state: Santa Fe
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Penrith
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead Nsw
country: Australia
facility: Local Institution
state: New South Wales
city: Greenslopes Qld
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: Prahran
country: Australia
facility: Local Institution
state: Victoria
city: Linz
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Hvidovre
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Besancon
country: France
facility: Local Institution
city: Bondy Cedex
country: France
facility: Local Institution
city: Grenoble Cedex 09
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Paris Cedex 12
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Koeln
country: Germany
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Nazareth
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Zefat
country: Israel
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Chorzow
country: Poland
facility: Local Institution
city: Kielce
country: Poland
facility: Local Institution
city: Myslowice
country: Poland
facility: Local Institution
city: Raciborz
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Alcorcon
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Scotland
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Scotland
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: