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The study enrollment was terminated early by the sponsor due to recruitment challenges.
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The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilofexor | Experimental | Participants will receive escalating doses of cilofexor 30 mg, 60 mg, and 100 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilofexor | Drug | Tablets administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAEs) were either defined any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. | First dose date up to 12 weeks plus 30 days |
| Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (SAEs) | A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death ; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes constituting SAEs. | First dose date up to 12 weeks plus 30 days |
| Percentage of Participants Who Experienced Laboratory Abnormalities | Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening. | First dose date up to 12 weeks plus 30 days |
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Key Inclusion Criteria:
Diagnosis PSC based on cholangiogram (magnetic resonance cholangiopancreatography [MRCP], endoscopic retrograde cholangiopancreatography [ERCP], or percutaneous transhepatic cholangiogram [PTC]) or liver biopsy
Individuals have evidence of cirrhosis based on historical liver biopsy, abdominal imaging [magnetic resonance imaging (MRI), computed tomography (CT), or Ultrasound], or a screening FibroScan®, enhanced liver fibrosis (ELF)™, or FibroTest®.
Individual has the following laboratory parameters at the Screening visit, as determined by the central laboratory:
Key Exclusion Criteria:
Current or prior history of any of the following
Model for End-stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
Current moderate to severely active inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Liver Health | Chandler | Arizona | 85224 | United States | ||
| California Liver Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38976363 | Derived | Levy C, Caldwell S, Mantry P, Luketic V, Landis CS, Huang J, Mena E, Maheshwari R, Rank K, Xu J, Malkov VA, Billin AN, Liu X, Lu X, Barchuk WT, Watkins TR, Chung C, Myers RP, Kowdley KV. Cilofexor in Patients With Compensated Cirrhosis Due to Primary Sclerosing Cholangitis: An Open-Label Phase 1B Study. Clin Transl Gastroenterol. 2024 Aug 1;15(8):e00744. doi: 10.14309/ctg.0000000000000744. |
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18 participants were screened.
Participants were enrolled at study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilofexor | Cilofexor 30 mg tablet orally once daily from Week 1 to Week 4, followed by cilofexor 60 mg (2 X 30 mg) tablets orally once daily from Week 5 to Week 8, followed by cilofexor 100 mg tablet orally once daily from Week 9 to Week 12. Participants received cilofexor for a total duration of 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 15, 2021 | Jul 19, 2022 |
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| Pasadena |
| California |
| 91105 |
| United States |
| University of California San Francisco, Liver Clinic | San Francisco | California | 94143 | United States |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| Minnesota Gastroenterology, PA | Maplewood | Minnesota | 55117 | United States |
| Northwell Health Center for Liver Diseases and Transplantation | Manhasset | New York | 11030 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | United States |
| VCU Clinical Research Services Unit (CRSU) [Patient Site Address] | Richmond | Virginia | 23298 | United States |
| University of Washington at Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilofexor | Cilofexor 30 mg tablet orally once daily from Week 1 to Week 4, followed by cilofexor 60 mg (2 X 30 mg) tablets orally once daily from Week 5 to Week 8, followed by cilofexor 100 mg tablet orally once daily from Week 9 to Week 12. Participants received cilofexor for a total duration of 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAEs) were either defined any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. | Safety Analysis Set included all participants who took at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose date up to 12 weeks plus 30 days |
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| ||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (SAEs) | A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death ; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes constituting SAEs. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to 12 weeks plus 30 days |
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| |||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experienced Laboratory Abnormalities | Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to 12 weeks plus 30 days |
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All-Cause Mortality: Enrollment up to 17 weeks; Adverse Events: First dose date up to 12 weeks plus 30 days
All-cause mortality: All enrolled analysis set included all participants who received a study participant identification number in the study after screening.
Adverse events: Safety analysis set included all participants who took at least 1 dose of study drug.
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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 | Cilofexor | Cilofexor 30 mg tablet orally once daily from Week 1 to Week 4, followed by cilofexor 60 mg (2 X 30 mg) tablets orally once daily from Week 5 to Week 8, followed by cilofexor 100 mg tablet orally once daily from Week 9 to Week 12. Participants received cilofexor for a total duration of 12 weeks. | 0 | 11 | 0 | 11 | 9 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Defaecation urgency | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Fatigue | General disorders | 24.1 | Systematic Assessment |
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| Ill-defined disorder | General disorders | 24.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | 24.1 | Systematic Assessment |
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| Jaw fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
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| Lip injury | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 24.1 | Systematic Assessment |
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| Menopausal symptoms | Reproductive system and breast disorders | 24.1 | Systematic Assessment |
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| Oligomenorrhoea | Reproductive system and breast disorders | 24.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2021 | Jul 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000717094 | cilofexor |
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