IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial record 1 of 2 for:
mdx-1106 hcv
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Intervention Model: Single Group Assignment Masking: Double Blind (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 |
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 ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703469
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:
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 ) |
| Study First Received: | June 19, 2008 |
| Last Updated: | April 22, 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 |
ClinicalTrials.gov processed this record on June 26, 2017