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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

June 19, 2008
April 22, 2010
October 2008
October 2009   (final data collection date for primary outcome measure)
safety, tolerability, and immunogenicity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00703469 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • Drug: MDX1106-02
    Single dose
  • Drug: Placebo
    Placebo single dose
  • Experimental: 1
    Intervention: Drug: MDX1106-02
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Gardiner D, Lalezari J, Lawitz E, DiMicco M, Ghalib R, Reddy KR, Chang KM, Sulkowski M, Marro SO, Anderson J, He B, Kansra V, McPhee F, Wind-Rotolo M, Grasela D, Selby M, Korman AJ, Lowy I. A randomized, double-blind, placebo-controlled assessment of BMS-936558, a fully human monoclonal antibody to programmed death-1 (PD-1), in patients with chronic hepatitis C virus infection. PLoS One. 2013 May 22;8(5):e63818. doi: 10.1371/journal.pone.0063818. Print 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2009
October 2009   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00703469
MDX1106-02, CA209-002
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP