AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH
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ClinicalTrials.gov Identifier: NCT03028740 |
Recruitment Status :
Recruiting
First Posted : January 23, 2017
Last Update Posted : October 8, 2019
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Sponsor:
Tobira Therapeutics, Inc.
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | January 13, 2017 | ||||
First Posted Date ICMJE | January 23, 2017 | ||||
Last Update Posted Date | October 8, 2019 | ||||
Actual Study Start Date ICMJE | April 20, 2017 | ||||
Estimated Primary Completion Date | October 14, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT03028740 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Effect of CVC compared to placebo on liver histology at Month 60 relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage AND no worsening of steatohepatitis [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH | ||||
Official Title ICMJE | AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis | ||||
Brief Summary | The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH. | ||||
Detailed Description | The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Subjects from Part 1 will continue into Part 2 and additional subjects will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Nonalcoholic Steatohepatitis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
2000 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 28, 2028 | ||||
Estimated Primary Completion Date | October 14, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Mexico, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, Slovenia, Spain, Switzerland, Taiwan, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03028740 | ||||
Other Study ID Numbers ICMJE | 3152-301-002 2016-004566-26 ( EudraCT Number ) 1001 ( Registry Identifier: Registro Nacional Estudios Clinicos (RNEC) ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Tobira Therapeutics, Inc. | ||||
Study Sponsor ICMJE | Tobira Therapeutics, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Tobira Therapeutics, Inc. | ||||
Verification Date | October 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |