A Study of MDX-1106 to Treat Patients With Hepatitis C Infection

A Phase I, Double-blind,Multicenter,Randomized,Placebo-controlled,Safety and Pharmacokinetic Dose-escalation Study of a Single Intravenous Administration of MDX-1106, a Fully Human Monoclonal Antibody to PD-1, in Subjects With Active Hepatitis C Genotype 1 Infection

This study examines the safety, tolerability, and immunogenicity of a single dose of MDX-1106 in patients with active hepatitis C genotype 1 or mixed hepatitis C genotype infection.

Inclusion Criteria:

• Infection with hepatitis C genotype 1 or mixed hepatitis C genotype;
• Asymptomatic or nearly asymptomatic from hepatitis C;
• Previous therapy with interferon and ribavirin or peginterferon and ribavirin without an SVR or relapsed following an SVR;or Interferon naive subjects
• Chronically infected (at least 6 months since diagnosis) HCV-positive subjects;
• No evidence of bridging necrosis or cirrhosis;
• Liver biopsy within the last 2 years

Exclusion Criteria:

• Acute hepatitis C infection
• History of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;