- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00703469
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection (MDX1106-02)
April 22, 2010 updated by: Bristol-Myers Squibb
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- Advanced Clinical Resesarch Institute
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San Francisco, California, United States, 94115
- Quest Clinical Research
-
-
Illinois
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Springfield, Illinois, United States, 62701
- Springfield Clinic Infectious Diseases
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- John Hopkins University School of Medicine, Viral Hepatitis Center
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania School of Medicine
-
-
Texas
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Dallas, Texas, United States, 75203
- The Liver Institute at Methodist Dallas
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San Antonio, Texas, United States, 78215
- Alamo Medical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Single dose
|
Placebo Comparator: 2
|
Placebo single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety, tolerability, and immunogenicity
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
June 19, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (Estimate)
June 23, 2008
Study Record Updates
Last Update Posted (Estimate)
April 23, 2010
Last Update Submitted That Met QC Criteria
April 22, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
Other Study ID Numbers
- MDX1106-02
- CA209-002 (Other Identifier: BMS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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