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

Hepatitis C Clinical Trial

— MDX1106-02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703469
• Other study ID #: MDX1106-02
• Secondary ID: CA209-002
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2008
• Last updated: April 22, 2010
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: April 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• MDX1106-02
Single dose
• Placebo
Placebo single dose

Locations

Country	Name	City	State
United States	Advanced Clinical Resesarch Institute	Anaheim	California
United States	John Hopkins University School of Medicine, Viral Hepatitis Center	Baltimore	Maryland
United States	The Liver Institute at Methodist Dallas	Dallas	Texas
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania
United States	Alamo Medical Research	San Antonio	Texas
United States	Quest Clinical Research	San Francisco	California
United States	Springfield Clinic Infectious Diseases	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety, tolerability, and immunogenicity		One year	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm