Status:
COMPLETED
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Acute hepatitis C infection
- History of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00703469
Start Date
October 1 2008
End Date
October 1 2009
Last Update
April 23 2010
Active Locations (7)
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1
Advanced Clinical Resesarch Institute
Anaheim, California, United States, 92801
2
Quest Clinical Research
San Francisco, California, United States, 94115
3
Springfield Clinic Infectious Diseases
Springfield, Illinois, United States, 62701
4
John Hopkins University School of Medicine, Viral Hepatitis Center
Baltimore, Maryland, United States, 21287