Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
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|ClinicalTrials.gov Identifier: NCT03059446|
Recruitment Status : Terminated (This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.)
First Posted : February 23, 2017
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Nonalcoholic Steatohepatitis Liver Cirrhosis Non-alcoholic Fatty Liver Disease||Drug: Cenicriviroc||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)|
|Actual Study Start Date :||February 14, 2017|
|Actual Primary Completion Date :||January 5, 2021|
|Actual Study Completion Date :||January 5, 2021|
Cenicriviroc (CVC) 150 mg tablet once daily in the morning with food until CVC is commercially available or the study is terminated.
Cenicriviroc 150 mg tablet once daily in the morning with food.
Other Name: CVC
- Number of Participants with Treatment-emergent Adverse Events (AE) [ Time Frame: Day 1 until the drug is commercially available or the study is terminated (Approximately 2 Years) ]An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059446
|Study Director:||Eduardo B Martins||Allergan|