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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Placebo; Drug: MDX1106-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703469

MDX1106-02

CA209-002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MDX1106-02

2

Placebo Comparator group

Treatment:

Drug: Placebo