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

Phase 1 Completed 54 enrolled Bristol-Myers Squibb

RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start: 2008-10
Primary completion: 2009-10
Completion: 2009-10

Outcome

Met primary endpoint

paper achieved the primary study endpoint of a reduction in HCV RNA ≥0.5 log10 IU/mL PMID 23717490 ↗

Publications

Gardiner D, Lalezari J, Lawitz E, DiMicco M, Ghalib R, Reddy KR, Chang KM, Sulkowski M, Marro SO, Anderson J, He B, Kansra V, McPhee F, Wind-Rotolo M, Grasela D, Selby M, Korman AJ, Lowy I. A randomized, double-blind, placebo-controlled assessment of BMS-936558, a fully human monoclonal antibody to programmed death-1 (PD-1), in patients with chronic hepatitis C virus infection. PLoS One. 2013 May 22;8(5):e63818. doi: 10.1371/journal.pone.0063818. Print 2013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	0.03 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	10 mg/kg	Intravenous