None listed
Conditions
Interventions
-Product: Cenicriviroc (CVC) mesylate / Cenicriviroc mesylate placebo
-Concentration: 150mg/placebo
-Pharmaceutical form: 150 mg coated tablets
-Presentation: Bottles (with 30 coated tablets
Sponsors
Tobira Therapeutics, Inc., una subsidiaria de Allergan plc,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 18-75 years 2. Ability to understand and sign a written informed consent form (ICF) 3. Histological evidence of NASH based on central reading of the Screening biopsy slides a. Historical biopsy may be substituted for Screening biopsy to determine eligibility if the following are met: i. Historical biopsy was obtained no more than 180 days prior to the first day of screening ii. Hepatic tissue is available for central histologic evaluation Please see the protocol for more information
Exclusion criteria
Exclusion criteria: 1. Inability to undergo a liver biopsy 2. Hepatitis B surface antigen (HBsAg) positive 3. Hepatitis C antibody (HCVAb) positive with the following 2 exceptions: a. Subjects previously treated for viral hepatitis C with at least a 3-year period since documented sustained virologic response at Week 12 (post-treatment) may be eligible if all other eligibility criteria are met b. Subjects with presence of HCVAb but negative hepatitis C virus (HCV) ribonucleic acid (RNA) without treatment (i.e., spontaneous clearance) may be eligible if all other eligibility criteria are met Please see the protocol for more information
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Korea South, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kindgdom, United States
Contacts
Public ContactElizabeth Rospigliosi
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed