A Study of MDX-1106 to Treat Patients With Hepatitis C Infection
MDX1106-02
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
2 other identifiers
interventional
54
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2008
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedApril 23, 2010
April 1, 2010
1 year
June 19, 2008
April 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety, tolerability, and immunogenicity
One year
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Acute hepatitis C infection
- History of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Advanced Clinical Resesarch Institute
Anaheim, California, 92801, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Springfield Clinic Infectious Diseases
Springfield, Illinois, 62701, United States
John Hopkins University School of Medicine, Viral Hepatitis Center
Baltimore, Maryland, 21287, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Related Publications (1)
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.
PMID: 23717490DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 23, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
April 23, 2010
Record last verified: 2010-04