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Completed

NCT Number: NCT01012895

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Clichy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-790052

Drug

Tablets, Oral, 60 mg, once daily, 24 weeks

BMS-650032

Drug

Tablets, Oral, 600 mg, twice daily, 24 weeks

Pegylated-interferon alfa-2a

Drug

Syringe, Subcutaneous Injection, 180 µg, once weekly

Other names: Pegasys

Ribavirin

Drug

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 names: Copegus

Primary outcomes

  1. Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment

    Time frame: 12 weeks post treatment

Secondary outcomes

  1. 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

    Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Nov 13, 2009
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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