Clinical trial NCT01125189: Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
Official title: A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.


Eligibility criteria: Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
* HCV RNA viral load of ≥100,000 IU/mL
* No previous exposure to interferon, pegIFNα, or RBV
* Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
* Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
* Body mass index of 18 to 35 kg/m\^2

Exclusion Criteria:

* Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
* Evidence of a medical condition associated with chronic liver disease other than HCV
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Primary outcomes:
measure: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
timeFrame: Weeks 4 and 12
measure: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
timeFrame: Follow-up Week 24
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
timeFrame: From start of study treatment (day 1) up to follow-up Week 48
Secondary outcomes:
measure: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
timeFrame: Week 4
measure: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
timeFrame: Week 12
measure: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
timeFrame: Follow-up Week 12
measure: Percentage of Resistant Variants Associated With Virologic Failure
timeFrame: Follow-up Week 48
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists (Alds)
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Cli
state: California
city: San Diego
country: United States
facility: Desta Digestive Disease Medical Center
state: California
city: San Francisco
country: United States
facility: University Of California, San Francisco/Sf General Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Aurora
country: United States
facility: Transplant Center And Hepatology Clinic, B-154
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University Of Florida Hepatology
state: Florida
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Springfield
country: United States
facility: Claudia T. Martorell, Md, Llc
state: Massachusetts
city: Bronx
country: United States
facility: James J Peters Vamc
state: New York
city: Great Neck
country: United States
facility: James Sungsik Park, M.D. C.N.S.C.
state: New York
city: Monticello
country: United States
facility: Upper Delaware Valley Infectious Diseases, Pc
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill School Of Med
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center For Liver Disease
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Arlington
country: United States
facility: North Texas Research Institute
state: Texas
city: Houston
country: United States
facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead Nsw
country: Australia
facility: Local Institution
state: New South Wales
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Clayton Vic
country: Australia
facility: Local Institution
state: Victoria
city: Camperdown
country: Australia
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Aarhus
country: Denmark
facility: Local Institution
city: Hvidovre
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Shebin Elkom
country: Egypt
facility: Local Institution
state: Menoufiya
city: Cairo
country: Egypt
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: Marseille Cedex 08
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Paris Cedex 12
country: France
facility: Local Instituition
city: Paris Cedex 14
country: France
facility: Local Institution
city: Duesseldorf
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.