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Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01030432
Collaborator
(none)
285
Enrollment
40
Locations
4
Arms
32
Duration (Months)
7.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
285 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 2a: Arm 1

Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks

Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Names:
  • Pegasys

    • Drug: Ribavirin
    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
    Other Names:
  • Copegus

    		•
    Placebo Comparator: Phase 2a: Arm 2

    Drug: Placebo
    Tablets, Oral, 0 mg, twice daily, 48 weeks
    Other Names:
  • Pegasys

    • Drug: Peginterferon Alfa-2a
    Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
    Other Names:
  • Pegasys

    • Drug: Ribavirin
    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
    Other Names:
  • Copegus

    		•
    Experimental: Phase 2b: Arm 1

    Drug: BMS-650032
    Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response

    Drug: Placebo
    Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12

    Drug: Peginterferon Alfa-2a
    Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
    Other Names:
  • Pegasys

    • Drug: Ribavirin
    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
    Other Names:
  • Pegasys

    		•
    Placebo Comparator: Phase 2b: Arm 2

    Drug: Placebo
    Tablets, Oral, 0 mg, twice daily 24 weeks

    Drug: Peginterferon Alfa-2a
    Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
    Other Names:
  • Pegasys

    • Drug: Ribavirin
    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
    Other Names:
  • Copegus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs [12 weeks after first dose]

    2. Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA [Week 4]

    3. Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA [Week 12]

    4. Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [at follow-up Week 24]

    Secondary Outcome Measures

    1. Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 [Week 4]

    2. Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only) [at Week 12 (Stage 2 only)]

    3. Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only) [Week 12 (Stage 1 only)]

    4. Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12 [follow-up Week 12]

    5. Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only) [follow-up Week 24 (Stage 1 only)]

    6. Resistant variants associated with virologic failure [48 weeks after last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)

    • Subjects chronically infected with HCV genotype 4 (Phase 2b only)

    • HCV RNA viral load of ≥ 105 IU/mL at screening

    • BMI of 18 - 35 kg/m² at screening

    Exclusion Criteria:

    • Cirrhosis (Phase 2a only)

    • Decompensated cirrhosis (Phase 2b)

    • Co-infection with HBV or HIV

    • Hepatocellular carcinoma

    • Prior treatment with anti-HCV drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Alabama At Birmingham Birmingham Alabama United States 35294-0006
    2 Alabama Liver & Digestive Specialists (Alds) Montgomery Alabama United States 36116
    3 Florida Hospital Transplant Center Orlando Florida United States 32804
    4 Mercy Medical Center Baltimore Maryland United States 21202
    5 The Research Institute Springfield Massachusetts United States 01105
    6 Umass Memorial Medical Center Worcester Massachusetts United States 01655
    7 James J Peters Vamc Bronx New York United States 10468
    8 University Of North Carolina, Chapel Hill Chapel Hill North Carolina United States 27599
    9 Healthcare Research Consultants Tulsa Oklahoma United States 74135-2920
    10 Oregon Health Science Univ Portland Oregon United States 97239
    11 Hospital Of The University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    12 Gastro One Germantown Tennessee United States 38138
    13 Metropolitan Research Fairfax Virginia United States 22031
    14 Dean Clinic Madison Wisconsin United States 53715
    15 Local Institution Ciudad De Buenos Aires Buenos Aires Argentina C1121ABE
    16 Local Institution Prov. Buenos Aires Buenos Aires Argentina 1629
    17 Local Institution Prov De Santa Fe Santa Fe Argentina 2000
    18 Local Institution Buenos Aires Argentina C1181
    19 Local Institution Creteil Cedex France 94010
    20 Local Institution Marseille Cedex 08 France 13285
    21 Local Instituition Montpellier Cedex 5 France 34295
    22 Local Institution Paris Cedex 13 France 75651
    23 Local Institution Paris Cedex 14 France 75679
    24 Local Institution Vandoeuvre Les Nancy France 54511
    25 Local Institution Frankfurt Germany 60590
    26 Local Institution Heidelberg Germany 69120
    27 Local Institution Mainz Germany 55131
    28 Local Institution Wurzburg Germany 97080
    29 Local Institution Dublin Ireland DUBLIN 7
    30 Local Institution Torino Italy 10126
    31 Local Institution Alicante Spain 03010
    32 Local Institution Barcelona Spain 08035
    33 Local Institution Madrid Spain 28222
    34 Local Institution Malaga Spain 29010
    35 Local Institution Valencia Spain 46010
    36 Local Institution London Greater London United Kingdom E1 2AT
    37 Local Institution London Greater London United Kingdom SE5 9RS
    38 Local Institution London Greater London United Kingdom W2 1NY
    39 Local Institution Manchester Greater Manchester United Kingdom M8 5RB
    40 Local Institution Glasgow Lanarkshire United Kingdom G12 0YN

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01030432
    Other Study ID Numbers:
    • AI447-016
    • 2009-013652-69
    First Posted:
    Dec 11, 2009
    Last Update Posted:
    Oct 9, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis
    Ribavirin
    Peginterferon alfa-2a
    Interferon-alpha
    Asunaprevir

    Study Results

    No Results Posted as of Oct 9, 2015