Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

Hepatitis C Virus Clinical Trial

— HEPCAT  

Official title:

A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

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

• Hepatitis
• Hepatitis C
• Hepatitis C Virus

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

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form