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
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 70
Updated:	4/21/2016
Start Date:	December 2009
End Date:	February 2014

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.

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

We found this trial at

sites

San Jose Gastroenterology

San Jose, California 95116

from

San Jose, CA