Safety and Efficacy of BMS-790052 Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00874770

First received: April 2, 2009

Last updated: March 4, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 2, 2009

Last Updated Date

March 4, 2011

Start Date ^ICMJE

June 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00874770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects with rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) < 10 IU/mL at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Proportion of subjects with early virologic response (EVR), defined as ≥ 2 log10 decrease in HCV RNA from baseline at Week 12 (or HCV RNA < 10 IU/mL for subjects with baseline HCV RNA < 1000 IU/mL) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA , 10 IU/mL at follow-up Week 12 (SVR12) and Week 24 (SVR24), respectively [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA , 10 IU/mL at follow-up Week 12 (SVR12) and Week 24 (SVR24), respectively [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]
Resistant variants associated with clinical failure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Resistant variants associated with clinical failure [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Resistant variants associated with clinical failure [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
Resistant variants associated with clinical failure [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities and, [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of BMS-790052 Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

Official Title ^ICMJE

A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

Brief Summary

The purpose of this study is to identify one or more doses of BMS-790052, that when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient anti-Hepatitis C Virus (HCV) activity.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatitis C

Intervention ^ICMJE

Drug: BMS-790052
Tablets, Oral, 3 mg, Daily, 48 weeks
Drug: BMS-790052
Tablets, Oral, 10 mg, Daily, 48 weeks
Drug: BMS-790052
Tablets, Oral, 60 mg, Daily, 48 weeks
Drug: Placebo
Tablet, Oral, 0 mg, Daily 48 weeks
Drug: Peginterferon alpha-2a
Syringe, Subcutaneous, 180 ug, Weekly, 48 weeks

Other Name: Pegasys
Drug: ribavirin
Tablet, Oral, 1000 mg or 1200 mg, based on weight, Daily, 48 weeks

Other Name: Copegus

Study Arm (s)

Experimental: BMS-790052, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
Interventions:
- Drug: BMS-790052
- Drug: Peginterferon alpha-2a
- Drug: ribavirin
Experimental: BMS-790052, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
Interventions:
- Drug: BMS-790052
- Drug: Peginterferon alpha-2a
- Drug: ribavirin
Experimental: BMS-790052, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
Interventions:
- Drug: BMS-790052
- Drug: Peginterferon alpha-2a
- Drug: ribavirin
Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D)
Interventions:
- Drug: Placebo
- Drug: Peginterferon alpha-2a
- Drug: ribavirin

Publications *

Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hézode C, Lim JK, Bronowicki JP, Abrams GA, Bräu N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects chronically infected with Hepatitis C Virus (HCV) genotype 1
HCV ribonucleic acid (RNA) viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening
Treatment naive

Exclusion Criteria:

Women of Child Bearing Potential
Cirrhosis
Co infection with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France

Administrative Information

NCT Number ^ICMJE

NCT00874770

Other Study ID Numbers ^ICMJE

AI444-014, EUDRACT# 2009-010149-29

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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