A randomized, placebo‐controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis
Icahn School of Medicine at Mount Sinai · Sorbonne Université · +24 more institutions
Abstract
The aim of this study was to evaluate cenicriviroc (CVC), a dual antagonist of CC chemokine receptor types 2 and 5, for treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis (LF). A randomized, double-blind, multinational phase 2b study enrolled subjects with NASH, a nonalcoholic fatty liver disease activity score (NAS) ≥4, and LF (stages 1-3, NASH Clinical Research Network) at 81 clinical sites. Subjects (N = 289) were randomly assigned CVC 150 mg or placebo. Primary outcome was ≥2-point improvement in NAS and no worsening of fibrosis at year 1. Key secondary outcomes were: resolution of steatohepatitis (SH) and no worsening of fibrosis; improvement in fibrosis by ≥1 stage and no worsening of…
Citation impact
- FWCI
- 55.95
- Percentile
- 100%
- References
- 21
Authors
23- SLScott L. FriedmanCorresponding
Icahn School of Medicine at Mount Sinai
- VRVlad Ratziu
Sorbonne Université, Pitié-Salpêtrière Hospital
- SAStephen A. Harrison
Pinnacle Clinical Research
- MFManal F. Abdelmalek
Duke University
- GPGuruprasad P. Aithal
Nottingham University Hospitals NHS Trust, University of Nottingham, National Institute for Health and Care Research, Nottingham Biomedical Research Centre
Topics & keywords
- Medicine
- Internal medicine
- Placebo
- Clinical endpoint
- Tolerability
- Gastroenterology
- Fibrosis
- Nonalcoholic fatty liver disease
- Good health and well-being