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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01170962
Other study ID # AI444-011
Secondary ID 2010-019378-34
Status Completed
Phase Phase 2
First received July 16, 2010
Last updated September 11, 2015
Start date August 2010
Est. completion date December 2012

Study information

Verified date September 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilCanada: Health CanadaCanada: Regulatory Affairs Division Office of Clinical Trials Therapeutic Products DirectorateDenmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyMexico: Federal Commission for Sanitary Risks ProtectionSweden: Medical Products AgencySweden: The National Board of Health and WelfareSweden: The Swedish Data Inspection BoardSweden: Central Ethics BoardUnited States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.


Recruitment information / eligibility

Status Completed
Enrollment 512
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Subjects chronically infected with HCV genotype 1

- Non-responder to prior therapy with peginterferon alfa and ribavirin

- HCV RNA viral load of 100,00 IU/mL

- Results of a liver biopsy = 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)

- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma

- Body Mass Index (BMI) of 18 to 35 kg/m2

Exclusion Criteria:

- Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening

- Evidence of medical condition associated with chronic liver disease other than HCV

- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Placebo
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks

Locations

Country Name City State
Argentina Local Institution Ciudad De Buenos Aires Buenos Aires
Argentina Local Institution Ciudad De Buenos Aires Buenos Aires
Argentina Local Institution Prov De Santa Fe Santa Fe
Australia Local Institution Clayton Victoria
Australia Local Institution Fremantle Western Australia
Australia Local Institution Heidelberg Victoria
Australia Local Institution Perth Western Australia
Australia Local Institution Prahan Victoria
Australia Local Institution Randwick New South Wales
Canada Local Institution Edmonton Alberta
Canada Local Institution Toronto Ontario
Canada Local Institution Toronto Ontario
Canada Local Institution Vancouver British Columbia
Canada Local Institution Victoria British Columbia
Denmark Local Institution Aarhus
Denmark Local Institution Hvidovre
Denmark Local Institution Odense
France Local Institution Clichy Cedex
France Local Institution Creteil Cedex
France Local Institution Lyon Cedex 04
France Local Institution Nice Cedex 03
France Local Institution Paris Cedex
France Local Institution Paris Cedex 14
France Local Institution Vandoeuvre Les Nancy
Germany Local Institution Essen
Germany Local Institution Frankfurt
Germany Local Institution Hamburg
Germany Local Institution Hannover
Italy Local Institution Cisanello (pisa)
Italy Local Institution Pavia
Mexico Local Institution Cuernavaca Morelos
Mexico Local Institution Guadalajara Jalisco
Mexico Local Institution Monterrey Nuevo Leon
Puerto Rico Instituto De Investigacion Cientifica Del Sur Ponce
Puerto Rico Local Institution San Juan
Sweden Local Institution Gothenburg
Sweden Local Institution Stockholm
United States Samuel S. Stratton Vamc Albany New York
United States North Texas Research Institute Arlington Texas
United States Transplant Center And Hepatology Clinic, B-154 Aurora Colorado
United States Digestive Disease Associates, P.A. Baltimore Maryland
United States Mercy Medical Center Baltimore Maryland
United States James J Peters Vamc Bronx New York
United States University Of North Carolina, Chapel Hill Chapel Hill North Carolina
United States Metropolitan Research Fairfax Virginia
United States University Of Florida Hepatology Gainesville Florida
United States James Sungsik Park, M.D. C.N.S.C. Great Neck New York
United States Liver Associates Of Texas Houston Texas
United States St. Luke'S Episcopal Hospital - Baylor College Of Medicine Houston Texas
United States Indiana University Indianapolis Indiana
United States Scripps Clinic La Jolla California
United States CLI Los Angeles California
United States Johns Hopkins Medical Institutions Lutherville Maryland
United States Dean Clinic Madison Wisconsin
United States Alabama Liver & Digestive Specialists (Alds) Montgomery Alabama
United States Upper Delaware Valley Infectious Diseases, Pc Monticello New York
United States Nashville Medical Research Institute Nashville Tennessee
United States Yale University School Of Medicine New Haven Connecticut
United States Ochsner Clinic Foundation New Orleans Louisiana
United States University Of Pennsylvania Philadelphia Pennsylvania
United States University Gastroenterology Providence Rhode Island
United States University Of Rochester Medical Center Rochester New York
United States Alamo Medical Research San Antonio Texas
United States Desta Digestive Disease Medical Center San Diego California
United States California Pacific Medical Center San Francisco California
United States Kaiser Permanente Medical Center San Francisco California
United States University Of California At San Francisco San Francisco California
United States Miami Research Associates South Miami Florida
United States The Research Institute Springfield Massachusetts
United States Saint Louis University St. Louis Missouri
United States Carolinas Center For Liver Disease Statesville North Carolina
United States Healthcare Research Consultants Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Denmark,  France,  Germany,  Italy,  Mexico,  Puerto Rico,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Extended Rapid Virologic Response (eRVR) eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. Week 4, Week 12 No
Primary Percentage of Participants With 24-week Sustained Virologic Response (SVR24) SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA Follow-up Week 24 No
Primary Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. From first dose to last dose plus 7 days, up to 49 weeks Yes
Primary Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. From day 8 post last dose of treatment up-to Week 72 Yes
Secondary Percentage of Participants With Rapid Virologic Response (RVR) RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Week 4 No
Secondary Percentage of Participants With Complete Early Virologic Response (cEVR) cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Week 12 No
Secondary Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Follow-up Week 12 No
Secondary Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C. Baseline to follow-up Week 48 No
Secondary Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H. Baseline to follow-up Week 48 No
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