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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C | Drug: MDX1106-02 Drug: Placebo | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: MDX1106-02
Single dose
|
Placebo Comparator: 2 |
Drug: Placebo
Placebo single dose
|
- safety, tolerability, and immunogenicity [ Time Frame: One year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

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
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
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 |