Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects - Full Text View

Purpose

At least 1 dose of BMS-790052 combined with Standard of Care (pegylated interferon and ribavirin) can be identified which is safe, well tolerated, and demonstrates extended rapid virologic response rates at least 35% greater than placebo.

Condition	Intervention	Phase
Hepatitis C Virus	Drug: BMS-790052 Drug: Placebo Drug: peg-interferon alfa-2a Drug: ribavirin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2b Study of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with extended rapid virologic response, defined as undetectable HCV RNA [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response, defined as undetectable HCV RNA [ Time Frame: Follow up Week 24 ] [ Designated as safety issue: No ]
Safety, as measured by the frequency of Serious Adverse Events and discontinuations due to Adverse Events [ Time Frame: Week 12, Week 24, and follow-up Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the proportion of HCV genotype 1 subjects with rapid virologic response, ie, undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
To assess the proportion of HCV genotype 1 subjects with complete early virologic response, ie, undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
To assess the proportion of HCV genotype 1 subjects with 12-week sustained virologic response, ie, undetectable HCV RNA [ Time Frame: follow-up Week 12 ] [ Designated as safety issue: No ]
To describe resistant variants associated with virologic failure [ Time Frame: follow-up Week 48 ] [ Designated as safety issue: No ]

Enrollment:	395
Study Start Date:	July 2010
Study Completion Date:	August 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BMS-790052 plus peg-interferon alfa-2a and ribavirin (20 mg)	Drug: BMS-790052 Tablets, Oral, 20 mg, Once daily, 12-24 weeks, depending on response Drug: peg-interferon alfa-2a Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response Other Name: Pegasys Drug: ribavirin Tablets, Oral, 1000 or 1200 mg based on weight, Once daily, 24 or 48 weeks depending on response Other Name: Copegus
Experimental: BMS-790052 plus peg-interferon alfa-2a and ribavirin (60 mg)	Drug: BMS-790052 Tablets, Oral, 60 mg, Once daily, 12-24 weeks, depending on response Drug: peg-interferon alfa-2a Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response Other Name: Pegasys Drug: ribavirin Tablets, Oral, 1000 or 1200 mg based on weight, Once daily, 24 or 48 weeks depending on response Other Name: Copegus
Placebo Comparator: Placebo plus peg-interferon alfa-2a and ribavirin	Drug: Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks Drug: peg-interferon alfa-2a Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response Other Name: Pegasys Drug: ribavirin Tablets, Oral, 1000 or 1200 mg based on weight, Once daily, 24 or 48 weeks depending on response Other Name: Copegus

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects chronically infected with 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 HCV 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)
Ultrasound, CT scan, or MRI results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
Body Mass Index (BMI) of 18 to 35 kg/m²

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125189

Show 30 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01125189 History of Changes
Other Study ID Numbers:	AI444-010, 2010-018295-24
Study First Received:	May 17, 2010
Last Updated:	March 28, 2013
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council Canada: Health Canada Canada: Regulatory Affairs Division Office of Clinical Trials Therapeutic Products Directorate Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: The Danish National Committee on Biomedical Research Ethics Egypt: National Ethic Committee Egypt: Ministry of Health, Drug Policy and Planning Center France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Mexico: Federal Commission for Sanitary Risks Protection Sweden: Medical Products Agency Sweden: The National Board of Health and Welfare Sweden: The Swedish Data Inspection Board Sweden: Central Ethics Board United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin

Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013

Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects (HEPCAT)