Chronic Hepatitis C
Conditions
Brief summary
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.
Interventions
DRUGBMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
DRUGBMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Syringe, Subcutaneous Injection, 180 µg, once weekly
DRUGRibavirin
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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment | 12 weeks post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks post-treatment | 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. | Day 1 and Day 14 | — |
| 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. | Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16 | — |
| 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. | Day 1 and Day 14 | — |
| 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. | Day 1 and Day 14 | — |
Countries
France, Puerto Rico, United States
Outcome results
None listed