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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00703469

Acronym

MDX1106-02

Enrollment

Registered

2008-06-23

Start date

2008-10-31

Completion date

2009-10-31

Last updated

2010-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hep C

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.

Interventions

DRUGMDX1106-02

Single dose

DRUGPlacebo

Placebo single dose

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame
safety, tolerability, and immunogenicity	One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026