Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 2 for:    mdx-1106 hcv
Previous Study | Return to List | Next Study

A Study of MDX-1106 to Treat Patients With Hepatitis C Infection (MDX1106-02)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00703469
First received: June 19, 2008
Last updated: April 22, 2010
Last verified: April 2010
  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
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

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 by Bristol-Myers Squibb

Additional 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
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 C
Hepatitis
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014