Non-alcoholic fatty liver disease (NAFLD) - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Tobira Therapeutics, Inc.

Recruitment countries:

Australia,  Belgium,  France,  Germany,  Hong Kong,  Italy,  Poland,  Spain,  United Kingdom,  United States

Health condition studied:

Liver Cirrhosis

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: Cenicriviroc

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  -Successful completion of both Treatment Period 1 and Treatment Period 2, of the CENTAUR
  Study (652-2-203), including a Year 2 liver biopsy.
  
  Exclusion Criteria:
  
  - Prior or planned liver transplantation
  
  - Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary
  biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's
  disease, hemochromatosis, or iron overload, or Alpha-1-antitrypsis (A1AT) deficiency.
  

• Age minimum:  18 Years
• Age maximum:  75 Years
• Gender:  All

Primary outcomes:

Number of Participants with Treatment-emergent Adverse Events (AE)

Secondary outcomes:

Target sample size:

200

Study type:

Interventional

Study design:

Contacts:

• Name:   William Chang
• Address: 
• Phone: 
• Email: 
• Affiliation:  Tobira Therapeutics, Inc.

Technical details

Scientific title:

Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT03059446

Secondary ID:

2016-004754-15
3152-201-002

Register:

ClinicalTrials.gov

Date of registration:

03/02/2017

Date of first enrollment:

February 14, 2017

Last refreshed:

8 May 2017