A Study of MDX-1106 to Treat Patients With Hepatitis C Infection (MDX1106-02)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00703469
First received: June 19, 2008
Last updated: April 22, 2010
Last verified: April 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: MDX1106-02 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- safety, tolerability, and immunogenicity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
| Enrollment: | 54 |
| Study Start Date: | October 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: MDX1106-02
Single dose
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo single dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703469
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
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00703469 History of Changes |
| Other Study ID Numbers: | MDX1106-02, CA209-002 |
| Study First Received: | June 19, 2008 |
| Last Updated: | April 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Hep C |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 13, 2013