Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis (CENTAUR)
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ClinicalTrials.gov Identifier: NCT02217475 |
Recruitment Status :
Completed
First Posted : August 15, 2014
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
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Sponsor:
Tobira Therapeutics, Inc.
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Nonalcoholic Steatohepatitis |
Interventions |
Drug: Cenicriviroc Drug: Placebo |
Enrollment | 289 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | In total, 812 participants were screened, and 289 participants were randomized to treatment period 1. Of the 289 participants randomized, 250 participants completed Treatment Period 1. A total of 242 participants entered Treatment Period 2 and 212 completed. |
Arm/Group Title | Placebo/Placebo | Placebo/Cenicriviroc (CVC) 150 mg | CVC 150mg/CVC 150 mg |
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Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2. | Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2. | CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2. |
Period Title: Treatment Period 1 (Year 1) | |||
Started | 72 | 72 | 145 |
Safety Analysis Set [1] | 72 | 72 | 144 |
Completed | 62 | 64 | 124 |
Not Completed | 10 | 8 | 21 |
Reason Not Completed | |||
Protocol Deviation (with non-compliance) | 0 | 1 | 0 |
Adverse Event | 4 | 5 | 9 |
Lost to Follow-up | 1 | 0 | 0 |
Subject Withdrew Consent | 5 | 2 | 11 |
Other Miscellaneous Reasons | 0 | 0 | 1 |
[1]
Received at least one dose of study drug.
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Period Title: Discontinued After Period 1 | |||
Started | 62 | 64 | 124 |
Completed | 60 | 61 | 121 |
Not Completed | 2 | 3 | 3 |
Reason Not Completed | |||
Adverse Event | 1 | 2 | 0 |
Participant Withdrew Consent | 1 | 1 | 2 |
Physician Decision | 0 | 0 | 1 |
Period Title: Treatment Period 2 (Year 2) | |||
Started | 60 | 61 | 121 |
Completed | 58 | 59 | 109 |
Not Completed | 2 | 2 | 12 |
Reason Not Completed | |||
Adverse Event | 0 | 1 | 5 |
Lost to Follow-up | 0 | 1 | 2 |
Subject Withdrew Consent | 2 | 0 | 2 |
Physician Decision | 0 | 0 | 2 |
Other Miscellaneous Reasons | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | CVC 150mg/CVC 150 mg | Placebo/Cenicriviroc (CVC) 150 mg | Placebo/Placebo | Total | |
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CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2. | Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2. | Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2. | Total of all reporting groups | |
Overall Number of Baseline Participants | 145 | 72 | 72 | 289 | |
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Intent-to-treat (ITT) population included all randomized participants regardless of starting treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 145 participants | 72 participants | 72 participants | 289 participants | |
54.6 (10.22) | 55.3 (10.38) | 52.1 (11.37) | 54.1 (10.59) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | 72 participants | 72 participants | 289 participants | |
Female |
73 50.3%
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39 54.2%
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40 55.6%
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152 52.6%
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Male |
72 49.7%
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33 45.8%
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32 44.4%
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137 47.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 145 participants | 72 participants | 72 participants | 289 participants |
Hispanic or Latino |
23 15.9%
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18 25.0%
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7 9.7%
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48 16.6%
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Not Hispanic or Latino |
122 84.1%
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51 70.8%
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65 90.3%
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238 82.4%
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Not reported |
0 0.0%
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2 2.8%
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0 0.0%
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2 0.7%
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Unknown |
0 0.0%
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1 1.4%
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0 0.0%
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1 0.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 145 participants | 72 participants | 72 participants | 289 participants |
Asian |
6 4.1%
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6 8.3%
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9 12.5%
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21 7.3%
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American Indian or Alaska Native |
0 0.0%
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0 0.0%
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1 1.4%
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1 0.3%
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Black or African American |
5 3.4%
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1 1.4%
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2 2.8%
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8 2.8%
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Native Hawaiian or Other Pacific Islander |
3 2.1%
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0 0.0%
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0 0.0%
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3 1.0%
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White |
129 89.0%
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63 87.5%
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58 80.6%
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250 86.5%
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Other |
2 1.4%
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2 2.8%
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2 2.8%
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6 2.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: | Therapeutic Area, Head |
Organization: | Allergan |
Phone: | 714-246-4500 |
EMail: | clinicaltrials@allergan.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tobira Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02217475 |
Other Study ID Numbers: |
652-2-203 2016-004754-15 ( EudraCT Number ) |
First Submitted: | August 13, 2014 |
First Posted: | August 15, 2014 |
Results First Submitted: | April 19, 2019 |
Results First Posted: | May 10, 2019 |
Last Update Posted: | May 10, 2019 |