Trial Outcomes & Findings for Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis (NCT NCT03059446)
NCT ID: NCT03059446
Last Updated: 2022-02-02
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Day 1 until the study was terminated (up to approximately 4 years)
Results posted on
2022-02-02
Participant Flow
Participants who completed the CENTAUR study \[NCT02217475\] or the AURORA study \[NCT03028740\] were eligible for enrollment in this rollover study.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
167
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Withdrawal of Consent
|
16
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
131
|
|
Overall Study
Reason not Specified
|
5
|
Baseline Characteristics
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Cenicriviroc (CVC) 150 mg
n=167 Participants
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
|
|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 10.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
150 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cenicriviroc (CVC) 150 mg
n=167 Participants
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AE)
|
140 Participants
|
Adverse Events
Cenicriviroc (CVC) 150 mg
Serious events: 40 serious events
Other events: 98 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cenicriviroc (CVC) 150 mg
n=167 participants at risk
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.8%
3/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Cardiac disorders
Angina unstable
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Cardiac disorders
Coronary artery occlusion
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Cardiac disorders
Tachycardia
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Ear and labyrinth disorders
Vertigo
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Eye disorders
Retinal artery occlusion
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Food poisoning
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
General disorders
Asthenia
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
2/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Cellulitis
|
1.8%
3/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Pneumonia legionella
|
1.2%
2/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Sepsis
|
1.2%
2/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Bone abscess
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Carbuncle
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Empyema
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Gastroenteritis
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Liver abscess
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Pneumonia
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Q fever
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Investigations
Weight decreased
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
3/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Metabolism and nutrition disorders
Gout
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
2/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
1.2%
2/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.1%
1/88 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Nervous system disorders
Dizziness
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Nervous system disorders
Headache
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Nervous system disorders
Migraine with aura
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Nervous system disorders
Syncope
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
3/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Vascular disorders
Hypertension
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Vascular disorders
Lymphatic fistula
|
0.60%
1/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
Other adverse events
| Measure |
Cenicriviroc (CVC) 150 mg
n=167 participants at risk
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
20/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Nausea
|
7.8%
13/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
7.2%
12/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.2%
12/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Gastrointestinal disorders
Constipation
|
7.2%
12/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
General disorders
Fatigue
|
6.0%
10/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
17/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Influenza
|
8.4%
14/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Bronchitis
|
7.2%
12/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Sinusitis
|
5.4%
9/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
9/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
10/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.2%
12/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
22/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
9/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
13/167 • Day 1 until the study was terminated (Up to approximately 4 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER