NCT00703469CompletedPhase 1
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
Bristol-Myers Squibb7 sites in 1 country54 target enrollmentStarted: October 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 7
- Primary Endpoint
- safety, tolerability, and immunogenicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
1
Experimental
Intervention: MDX1106-02 (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
safety, tolerability, and immunogenicity
Time Frame: One year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
Loading locations...
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