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Protocol 3152-301-002
Title A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis.
Phase III
Area Liver
Indication Nonalcoholic Steatohepatitis
Treatment Study duration is 12 months for Part 1 and 84 months for Part 2 with subjects randomized in 2:1 fashion. Cenicriviroc mesylate (CVC) is a novel, once-daily, orally active and potent inhibitor of ligand binding to C-C chemokine receptor (CCR) type 2 (CCR2) and type 5 (CCRg).
Requirement Subject population consists of male or female subjects between 18 and 75 years of age with histologically proven NASH with fibrosis stage 2-3.
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