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

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ClinicalTrials.gov Identifier: NCT00703469
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : April 23, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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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

Study Design
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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

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: MDX1106-02
Single dose
Placebo Comparator: 2 Drug: Placebo
Placebo single dose


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

Eligibility Criteria
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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
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;
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00703469


Locations
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00703469     History of Changes
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:
Hepatitis C
Nivolumab
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs