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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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