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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00703469

Run by

Bristol-Myers Squibb

People needed

54

Starts

2008-10-01

Expected to finish

2009-10-01

Last updated by the study team

2010-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Advanced Clinical Resesarch Institute — Anaheim, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Springfield Clinic Infectious Diseases — Springfield, Illinois, United States
• John Hopkins University School of Medicine, Viral Hepatitis Center — Baltimore, Maryland, United States
• University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
• The Liver Institute at Methodist Dallas — Dallas, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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