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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00703469
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : April 23, 2010
Information provided by:
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: MDX1106-02 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : October 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: 1 Drug: MDX1106-02
Single dose

Placebo Comparator: 2 Drug: Placebo
Placebo single dose

Primary Outcome Measures :
  1. safety, tolerability, and immunogenicity [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00703469

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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00703469    
Other Study ID Numbers: MDX1106-02
CA209-002 ( Other Identifier: BMS )
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: April 2010
Keywords provided by Bristol-Myers Squibb:
Hep C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action