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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004754-15 | EudraCT Number |
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This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.
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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenicriviroc (CVC) 150 mg | Experimental | Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenicriviroc | Drug | Cenicriviroc immediate release tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 until the study was terminated (up to approximately 4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo B Martins | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast - Dothan | Dothan | Alabama | 36305 | United States | ||
| Mayo Clinic Hospital |
Participants who completed the CENTAUR study [NCT02217475] or the AURORA study [NCT03028740] were eligible for enrollment in this rollover study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2018 | Dec 22, 2021 |
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| Phoenix |
| Arizona |
| 85054 |
| United States |
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | United States |
| Franco Felizarta, MDv | Bakersfield | California | 93301 | United States |
| University of California, San Diego (UCSD) | La Jolla | California | 92037 | United States |
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States |
| University of California, San Diego (UCSD) - Medical Center | San Diego | California | 92093 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| Upland Clinical Research | Upland | California | 91786 | United States |
| Island View Gastroenterology Associates | Ventura | California | 93003 | United States |
| University of Miami - Schiff Center for Liver Diseases | Miami | Florida | 33136 | United States |
| Advanced Medical Research | Port Orange | Florida | 32127 | United States |
| Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| Kansas Medical Clinic PA | Topeka | Kansas | 66606 | United States |
| Delta Research Partners, Llc | Bastrop | Louisiana | 71220 | United States |
| Tandem Clinical Research LLC | Marrero | Louisiana | 70072 | United States |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | United States |
| Mercy Medical Center - Baltimore, Maryland | Baltimore | Maryland | 21202 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Minnesota Gastroenterology, P.A. | Saint Paul | Minnesota | 55114 | United States |
| Digestive Health Specialists | Tupelo | Mississippi | 38801 | United States |
| University of Buffalo - Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center (DUMC) | Durham | North Carolina | 27710 | United States |
| Wake Research Associates, LLC - Raleigh | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Consultants for Clinical Research - Cincinnati | Cincinnati | Ohio | 45249 | United States |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| ClinSearch LLC | Chattanooga | Tennessee | 37421 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Digestive Health Research | Lebanon | Tennessee | 37090 | United States |
| The University of Texas - Health Science Center & Medical School at Houston | Houston | Texas | 77030 | United States |
| The Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University Medical College of Virginia | Richmond | Virginia | 23249 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Royal Brisbane Hospital and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Central Adelaide Local Health Network Inc - Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| University Hospital Erasmus (Brussels) | Brussels | 1070 | Belgium |
| UCL Saint Luc Bruxelles | Brussels | 1200 | Belgium |
| Antwerp University Hospital (UZA) | Edegem | 2650 | Belgium |
| CHU Angers | Angers | 49933 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Purpan CHU Toulouse | Toulouse | 31059 | France |
| Uniklinik RWTH Aachen | Aachen | 52074 | Germany |
| Charite - University Hospital Berlin - Campus Virchow - Hospital | Berlin | 13353 | Germany |
| Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP) | Cologne | 50937 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik | Hamburg | 20246 | Germany |
| Universitaetsklinikum Heidelberg - Innere Medizin IV | Heidelberg | 69120 | Germany |
| Eugastro GmbH | Leipzig | 4103 | Germany |
| University Hospital Giessen and Marburg GmbH | Marburg | 35043 | Germany |
| Prince of Wales Hospital | Shatin | Hong Kong | Hong Kong |
| Policlinico S. Orsola-Malpighi | Bologna | 40138 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano | Milan | 20122 | Italy |
| AOU Policlinico Paolo Giaccone di Palermo | Palermo | 90127 | Italy |
| ID Clinic | Mysłowice | 41-400 | Poland |
| Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p. | Wroclaw | 50-349 | Poland |
| Fundacion de Investigacion de Diego | San Juan | 927 | Puerto Rico |
| Hospital Universitario Vall d'Hebron | Barcelona | 8022 | Spain |
| Hospital de la Santa Creu i Sant Pau Barcelona | Barcelona | 8026 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Nottingham NHS Treatment Centre | Nottingham | NG7 2UH | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Population included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Day 1 until the study was terminated (up to approximately 4 years) |
|
|
|
Day 1 until the study was terminated (Up to approximately 4 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 1 | 167 | 40 | 167 | 98 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Q fever | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment | Number of participants at risk is based on the female population. |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Uraemic encephalopathy | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Vertebral artery stenosis | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Lymphatic fistula | Vascular disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2019 | Dec 22, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C506967 | cenicriviroc |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|