Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
Conditions
Brief summary
This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 \[NCT02217475\] or the AURORA study \[NCT03028740\].
Interventions
DRUGCenicriviroc
Cenicriviroc immediate release tablets
Sponsors
Tobira Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. * Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of: * Histopathological progression to cirrhosis * Model for end-stage liver disease (MELD) score ≥ 15 * Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic) * Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture).
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 antitrypsin (A1AT) deficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AE) | Day 1 until the study was terminated (up to approximately 4 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 the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug. |
Countries
Australia, Belgium, France, Germany, Hong Kong, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Participants who completed the CENTAUR study \[NCT02217475\] or the AURORA study \[NCT03028740\] were eligible for enrollment in this rollover study.
Participants by arm
| Arm | Count |
|---|---|
| Cenicriviroc (CVC) 150 mg Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years). | 167 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Reason not Specified | 5 |
| Overall Study | Study Terminated by Sponsor | 131 |
| Overall Study | Withdrawal of Consent | 16 |
Baseline characteristics
| Characteristic | Cenicriviroc (CVC) 150 mg |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 10.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 150 Participants |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 167 |
| other Total, other adverse events | 98 / 167 |
| serious Total, serious adverse events | 40 / 167 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (AE)
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 the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
Time frame: Day 1 until the study was terminated (up to approximately 4 years)
Population: Safety Population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cenicriviroc (CVC) 150 mg | Number of Participants With Treatment-emergent Adverse Events (AE) | 140 Participants |