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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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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:

BMS Clinical Trials Disclosure 

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 

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

Gardiner D, Lalezari J, Lawitz E, DiMicco M, Ghalib R, Reddy KR, Chang KM, Sulkowski M, Marro SO, Anderson J, He B, Kansra V, McPhee F, Wind-Rotolo M, Grasela D, Selby M, Korman AJ, Lowy I. A randomized, double-blind, placebo-controlled assessment of BMS-936558, a fully human monoclonal antibody to programmed death-1 (PD-1), in patients with chronic hepatitis C virus infection. PLoS One. 2013 May 22;8(5):e63818. doi: 10.1371/journal.pone.0063818. Print 2013.

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
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