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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

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;