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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: MDX1106-02; Drug: Placebo

• Registration Number: NCT00703469
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-23
• Study Start: 2008-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Read More

Exclusion Criteria

• Acute hepatitis C infection
• History of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MDX1106-02	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
safety, tolerability, and immunogenicity	One year

Trial Locations

Locations (7)

Advanced Clinical Resesarch Institute; 🇺🇸 Anaheim, California, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Springfield Clinic Infectious Diseases; 🇺🇸 Springfield, Illinois, United States

The Liver Institute at Methodist Dallas; 🇺🇸 Dallas, Texas, United States

University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

John Hopkins University School of Medicine, Viral Hepatitis Center; 🇺🇸 Baltimore, Maryland, United States

Alamo Medical Research; 🇺🇸 San Antonio, Texas, United States