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Completed

NCT Number: NCT00703469

A Study of MDX-1106 to Treat Patients With Hepatitis C 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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Clinical Resesarch Institute, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

MDX1106-02

Drug

Single dose

Placebo

Drug

Placebo single dose

Primary outcomes

  1. safety, tolerability, and immunogenicity

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: MDX1106-02

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2008
Registry last updated
Apr 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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