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A Study of MDX-1106 to Treat Patients With Hepatitis C Infection (MDX1106-02)

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: June 19, 2008
Last updated: April 22, 2010
Last verified: April 2010
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.

Condition Intervention Phase
Hepatitis C
Drug: MDX1106-02
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • safety, tolerability, and immunogenicity [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MDX1106-02
Single dose
Placebo Comparator: 2 Drug: Placebo
Placebo single dose


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
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Please refer to this study by its identifier: NCT00703469

United States, California
Advanced Clinical Resesarch Institute
Anaheim, California, United States, 92801
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Illinois
Springfield Clinic Infectious Diseases
Springfield, Illinois, United States, 62701
United States, Maryland
John Hopkins University School of Medicine, Viral Hepatitis Center
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
Alamo Medical Research
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00703469     History of Changes
Other Study ID Numbers: MDX1106-02  CA209-002 
Study First Received: June 19, 2008
Last Updated: April 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Hep C

Additional relevant MeSH terms:
Hepatitis C
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Antineoplastic Agents processed this record on May 26, 2016