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

Bristol-Myers Squibb215 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

215

Conditions

Chronic Hepatitis C

Interventions

BMS-790052DRUG

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

BMS-650032DRUG

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

BMS-650032DRUG

Tablets, Oral, 200mg, twice daily, 24 weeks

BMS-650032

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (18)

Advanced Clinical Research Institute

Anaheim, California, United States

Southern California Liver Centers

Coronado, California, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks post treatment

Secondary Outcomes

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

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

Time frame: 12 weeks post-treatment

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

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

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

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

Data from ClinicalTrials.gov

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