Back to resultsA Study of MDX-1106 to Treat Patients With Hepatitis C Infection (MDX1106-02)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDX1106-02
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hep C
Eligibility 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;
Sites / Locations
- Advanced Clinical Resesarch Institute
- Quest Clinical Research
- Springfield Clinic Infectious Diseases
- John Hopkins University School of Medicine, Viral Hepatitis Center
- University of Pennsylvania School of Medicine
- The Liver Institute at Methodist Dallas
- Alamo Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
safety, tolerability, and immunogenicity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00703469
Brief Title
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection
Acronym
MDX1106-02
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hep C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MDX1106-02
Intervention Description
Single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo single dose
Primary Outcome Measure Information:
Title
safety, tolerability, and immunogenicity
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Resesarch Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Springfield Clinic Infectious Diseases
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
John Hopkins University School of Medicine, Viral Hepatitis Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Liver Institute at Methodist Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23717490
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection
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