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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

MDX1106-02

Intervention Type DRUG

Single dose

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo single dose

Interventions

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MDX1106-02

Single dose

Intervention Type DRUG

Placebo

Placebo single dose

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No