Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01012895
First received: November 12, 2009
Last updated: May 5, 2014
Last verified: May 2014

November 12, 2009
May 5, 2014
December 2009
October 2012   (final data collection date for primary outcome measure)
Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
HCV blood samples to measure the level of HCV RNA from baseline (Day -1 or screening). Plasma HCV RNA levels will be measured [ Time Frame: at screening and on Days -1, 1 to 7, 9, 11, 14, Week 3 and every 2 weeks from Week 4 to Week 12, and every 4 Weeks from Week 12 to EOT and at Weeks 4, 12, 24, 36, 48 in subjects ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01012895 on ClinicalTrials.gov Archive Site
  • Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: Yes ]
    Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)
  • Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
  • Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results [ Time Frame: Day 14 and every 4 Weeks for the duration of the study to end of treatment ] [ Designated as safety issue: Yes ]
  • For Part 1 (sentinel cohorts only) treatment groups A and B: Pharmacokinetic parameters [Cmax, Cmin, Tmax, and AUC(TAU)] will be derived from plasma concentration versus time. C-trough and sparse PK samples will also be collected. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: BMS-790052
    Tablets, Oral, 60 mg, once daily, 24 weeks
  • Drug: BMS-650032
    Tablets, Oral, 600 mg, twice daily, 24 weeks
  • Drug: BMS-650032
    Tablets, Oral, 200mg, twice daily, 24 weeks
  • Drug: BMS-650032
    Tablets, Oral, 200 mg, once daily, 24 weeks
  • Drug: Pegylated-interferon alfa-2a
    Syringe, Subcutaneous Injection, 180 µg, once weekly
    Other Name: Pegasys
  • Drug: Ribavirin

    Tablets, Oral

    For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg

    Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

    Other Name: Copegus
  • Experimental: Arm 1: Sentinel A
    BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
    Interventions:
    • Drug: BMS-790052
    • Drug: BMS-650032
  • Experimental: Arm 2: Sentinel B
    BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
    Interventions:
    • Drug: BMS-790052
    • Drug: BMS-650032
    • Drug: Pegylated-interferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm 3: Expansion A1
    BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
    Interventions:
    • Drug: BMS-790052
    • Drug: BMS-650032
  • Experimental: Arm 4: Expansion A2
    BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
    Interventions:
    • Drug: BMS-790052
    • Drug: BMS-650032
  • Experimental: Arm 5: Expansion B1
    BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
    Interventions:
    • Drug: BMS-790052
    • Drug: BMS-650032
    • Drug: Pegylated-interferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm 6: Expansion B2
    BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
    Interventions:
    • Drug: BMS-790052
    • Drug: BMS-650032
    • Drug: Pegylated-interferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm 7: Expansion B3
    BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
    Interventions:
    • Drug: BMS-790052
    • Drug: BMS-650032
    • Drug: Ribavirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
February 2014
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects ages 18 to 70 years
  • HCV-Infected Genotype 1 Null responders to current standard of care
  • Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

Exclusion Criteria:

  • Evidence of a medical condition associate with chronic liver disease other than HCV
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
  • History of Cancer within 5 years of enrollment
  • History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
  • History of clinically significant cardiac disease
  • History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Documented cirrhosis within 12 months prior to dosing
  • Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
  • Pregnant
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Puerto Rico
 
NCT01012895
AI447-011, 2010-024637-23
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

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