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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000204-14 | EudraCT Number | ||
| jRCT2080224728 | Registry Identifier | Japan Registry of Clinical Trials |
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Following recommendation of the external Data Monitoring Committee, after it reviewed the results of a planned interim futility analysis.
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The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilofexor 100 mg (Blinded Phase) | Experimental | Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks. |
|
| Placebo (Blinded Phase) | Placebo Comparator | Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks. |
|
| Cilofexor From Cilofexor 100 mg (OLE Phase) | Experimental | Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks. |
|
| Cilofexor From Placebo (OLE Phase) | Experimental | Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilofexor | Drug | 100 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96 | Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis). | Blinded Phase Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase | An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: 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 and/or any AEs leading to premature discontinuation of study drug. |
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Key Inclusion Criteria:
Diagnosis of large duct PSC
Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
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:
Presence of a percutaneous drain or biliary stent
Other causes of liver disease
Current or prior history of unstable cardiovascular disease
Current moderate to severe 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 |
|---|---|---|---|---|---|---|
| Institute For Liver Health | Glendale | Arizona | 85306 | United States | ||
| The Institute for Liver Heath |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36922785 | Background | Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Farkkila M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2. | |
| Background | Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, et al. A Phase 3 Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Cilofexor in Patients With Non-cirrhotic Patients With Primary Sclerosing Cholangitis. J Hepatol. 2023 June;78(S1):S12-S13. | ||
| 41173015 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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587 participants were screened.
Participants were enrolled at study sites in Europe, North America, Oceania, and Asia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilofexor 100 mg (Blinded Phase) | Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks. |
| FG001 | Placebo (Blinded Phase) | Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Treatment Phase (100.3 Weeks) |
|
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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 | Mar 16, 2022 | Oct 5, 2023 |
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|
| Placebo | Drug | Tablet administered orally once daily |
|
| First dose date in the Blinded Phase up to 100.3 weeks plus 30 days |
| Percentage of Participants Who Experienced TEAEs in The OLE Phase | An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: 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 and/or any AEs leading to premature discontinuation of study drug. | First dose date in the OLE Phase up to 45 weeks plus 30 days |
| Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase | An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction. | First dose date in the Blinded Phase up to 100.3 weeks plus 30 days |
| Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase | An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction. | First dose date in the OLE Phase up to 45 weeks plus 30 days |
| Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 |
| Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 |
| Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 |
| Percentage of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96 | The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with ≥ 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed. | Baseline, Blinded Phase Week 96 |
| Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96 | Fibrosis improvement was defined as having ≥ 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis). | Blinded Phase Week 96 |
| Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96 | The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms. | Baseline, Blinded Phase Week 96 |
| Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96 | The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis. | Baseline, Blinded Phase Week 96 |
| Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96 | Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s). | Baseline, Blinded Phase Week 96 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Southern California Research Center | Coronado | California | 92118 | United States |
| Altman Clinical and Translational Research Institute (Clinic) | La Jolla | California | 92037 | United States |
| Scripps Clinic/Green Hospital | La Jolla | California | 92037 | United States |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | United States |
| Stanford Hospital | Palo Alto | California | 94025 | United States |
| California Liver Research Institute | Pasadena | California | 91105 | United States |
| University of California, Davis Medical Center (study visits) | Sacramento | California | 95817 | United States |
| Sutter Pacific Medical Foundation - California Pacific Medical Center | San Francisco | California | 94107 | United States |
| University of California, San Francisco Liver Clinic | San Francisco | California | 94143 | United States |
| Cedars Sinai Medical Center | West Hollywood | California | 90048 | United States |
| University of Colorado Denver and Hospital | Aurora | Colorado | 80045 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | United States |
| Yale School of Medicine | New Haven | Connecticut | 48109 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | United States |
| Advanced Research Institute, Inc | New Port Richey | Florida | 34653 | United States |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| Northwestern Memorial Hospital; Clinical Research Unit | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center (outpatient clinic) | Chicago | Illinois | 60637 | United States |
| NorthShore University Healthsystem | Evanston | Illinois | 60201 | United States |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| NECCR PrimaCare Research, LLC | Fall River | Massachusetts | 02721 | United States |
| Michigan Medicine - University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Minnesota Gastroenterology, PA | Maplewood | Minnesota | 55117 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Southern Therapy and Advanced Research LLC | Jackson | Mississippi | 39157 | United States |
| Saint Louis University, Gastroenterology & Hepatology | St Louis | Missouri | 63104 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Rutgers New Jersey Medical School - Doctors Office Center | Newark | New Jersey | 07103 | United States |
| Northwell Health Center for Liver Diseases and Transplantation | Manhasset | New York | 11030 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Icahn School of Medicine at Mount Sinai Beth Israel | New York | New York | 10029 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Center for Liver Disease and Transplantation, Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC) | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center - Center for Liver Disease | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Holmes Hospital | Cincinnati | Ohio | 45267 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 28204 | United States |
| Rapid City Medical Center, LLP | Rapid City | South Dakota | 57701 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University Medical Center - Digestive Disease Center | Nashville | Tennessee | 37232 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas | Dallas | Texas | 75246 | United States |
| Baylor Scott & White Medical Center at Fort Worth | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | United States |
| Spring Gastroenterology Associates | Humble | Texas | 77338 | United States |
| San Antonio Military Medical Center, Gastro/Hepatology | San Antonio | Texas | 78234 | United States |
| Intermountain Medical Center - Transplant Services | Murray | Utah | 84107 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Verity Research Inc. | Fairfax | Virginia | 22031 | United States |
| Bon Secours Richmond Community Hospital | Richmond | Virginia | 23226 | United States |
| Virginia Commonwealth University Clinical Research Services Unit | Richmond | Virginia | 23298 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| St. Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Nepean Hospital | Penrith | New South Wales | 2751 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Coral Sea Clinical Research Institute - Mackay | Auchenflower | Queensland | 4066 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Mater Misericordiae Ltd | South Brisbane | Queensland | 4101 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee | Klagenfurt | 9020 | Austria |
| Allgemeines Krankenhaus Wien | Vienna | 1090 | Austria |
| Hôpital Erasme - ULB | Brussels | 10070 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Algemeen Ziekenhuis Maria Middelares | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | B-3000 | Belgium |
| Centre Hospitalier Universitaire de Liège Site Sart Tilman | Liège | 4000 | Belgium |
| William Osler Health System - Brampton Civic Hospital | Brampton | L6R 3J7 | Canada |
| University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC) | Calgary | T2N 4Z6 | Canada |
| University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC) | Edmonton | T6G 2X8 | Canada |
| Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority | Halifax | B3L 1E4 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | L8N 4A6 | Canada |
| McMaster University Medical Center | Hamilton | L8S 4L8 | Canada |
| Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM) | Montreal | H2X 3J4 | Canada |
| Chronic Viral Illness Service/McGill University Health Centre (MUHC) | Montreal | H4A 3J1 | Canada |
| Toronto General Hospital - Toronto Centre for Liver Disease (TCLD) | Toronto | M5G 2C4 | Canada |
| Toronto Liver Centre | Toronto | M6H 3M1 | Canada |
| Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology | Vancouver | V5Z 1M9 | Canada |
| (G.I.R.I.) GI Research Institute | Vancouver | V6Z 2K5 | Canada |
| University of Manitoba/Health Sciences Centre | Winnipeg | R3E 3P4 | Canada |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Copenhagen University Hospital - Hvidovre | København Ø | DK-2100 | Denmark |
| Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala | Helsinki | 00290 | Finland |
| Turku University Hospital, Gastroenterology Outpatient Clinic | Turku | 20520 | Finland |
| Hôpital Saint-Eloi | Montpellier | Herault | 34295 | France |
| CHU Amiens-Picardie Hôpital Sud | Amiens | 80054 | France |
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez | CHRU Lille | 59000 | France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| CHU Grenoble Alpes | Grenoble | 38043 | France |
| Hôpital Saint-Joseph | Marseille | 13008 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| CHU Bordeaux-Hopital Haut-Leveque | Pessac | 33604 | France |
| Hopital Robert Debré - Centre Hospitalier Universitaire de Reims | Reims | 4025 | France |
| CHU de Strasbourg - Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| CHU de Toulouse Hopital Ranguiel | Toulouse | 31059 | France |
| CHU de Toulouse - Hopital Rangueil | Toulouse | 31300 | France |
| Hopital Paul Brousse | Villejuif | 94800 | France |
| GASTRO-Studien GbR | Berlin | 10825 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Medizinische Hochscule Hannover | Hanover | 30625 | Germany |
| Universitätsklinik Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie | Homburg | 66421 | Germany |
| Gastroenterologisch-Hepatologisches Zentrum Kiel | Kiel | 24146 | Germany |
| Universitätsklinikum Leipzig AöR | Leipzig | 04103 | Germany |
| Universitatsmedizin der Johannes Gutenberg-Universitat Mainz | Mainz | 55131 | Germany |
| Universitätsmedizin Mannheim, II. Medizinische Klinik | Mannheim | 68167 | Germany |
| Emek Medical Center | Afula | 1834111 | Israel |
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| Carmel Medical Center | Haifa | Israel |
| Shaare Zedek Medical Center | Jerusalem | 64239 | Israel |
| Hadassah University Hospital Ein Kerem | Jerusalem | 91120 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 62431 | Israel |
| IRCCS Ospedale Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Dipartimento Gastroenterologico e dei Trapianti | Ancona | 60126 | Italy |
| Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara | Bologna | 40138 | Italy |
| Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia | Milan | 20122 | Italy |
| Medicina Interna 1 | Novara | 28100 | Italy |
| Azienda Ospedale Universita Padova | Padova | 35128 | Italy |
| Azienda Ospedaliera Universitaria Policlinico P. Giaccone | Palermo | 90127 | Italy |
| Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia | Pisa | 56124 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | 00168 | Italy |
| U.O.C. Gatroenterologia | Rozzano | 20089 | Italy |
| Istituto Clinico Humanitas - Unita Operativa di Epatologia | Rozzano (Milan) | 20089 | Italy |
| Chiba University Hospital | Chiba | 260-8670 | Japan |
| Hiroshima University Hospital | Hiroshima | 7348551 | Japan |
| National Hospital Organization Nagasaki Medical Center | Nagasaki | 856-8562 | Japan |
| Okayama University Hospital | Okayama | 7008558 | Japan |
| National University Corporation Tohoku University Tohoku University Hospital | Sendai | 980-8574 | Japan |
| Osaka University Hospital | Suita | 565-0871 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Teikyo University Hospital | Tokyo | 173-8606 | Japan |
| Ehime University Hospital | Toon-Shi | 791-0295 | Japan |
| Yamagata University Hospital | Yamagata | 9909585 | Japan |
| Auckland City Hospital | Auckland | 92103 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Waikato Hospital | Hamilton | 2001 | New Zealand |
| Hospital General Universitario de Alicante | Alicante | 3010 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Ramon y cajal | Madrid | 28034 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | 28220 | Spain |
| Complejo Hospitalario de Pontevedra | Pontevedra | 36071 | Spain |
| Hospital Clinico Universitario Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitari Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Universitatsspital Bern | Bern | 3010 | Switzerland |
| Epatocentro Ticino SA | Lugano | 6900 | Switzerland |
| Universitatsspital Zurich | Zurich | 8091 | Switzerland |
| University Hospital Birmingham NHS Foundation Trust | Birmingham | B15 2TT | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | G4 0SF | United Kingdom |
| The Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| Aintree University Hospitals NHS Foundation Trust | Liverpool | L9 7AL | United Kingdom |
| Barts Health NHS Trust | London | E1 1BB | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9NT | United Kingdom |
| Chelsea and Westminster Hospital NHS Foundation Trust | London | SW10 9NH | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 9DU | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | PO6 3LY | United Kingdom |
| Derived |
| Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, Joshi D, Salminen K, Yimam K, Isayama H, Montano-Loza AJ, Caldwell S, Danta M, Farkkila M, Gallegos-Orozco JF, Gordon SC, Hinrichsen H, Invernizzi P, Vuppalanchi R, Zhu K, Xu J, Liu X, Lu X, Crans G, Bolbolan S, Boyette L, Alani M, Barchuk WT, Watkins TR, Genovese MC, Bowlus CL. Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):46-58. doi: 10.1016/S2468-1253(25)00208-0. Epub 2025 Oct 28. |
| FG002 | Cilofexor From Cilofexor 100 mg (OLE Phase) | Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks. |
| FG003 | Cilofexor From Placebo (OLE Phase) | Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Extension Phase (45 Weeks) |
|
|
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cilofexor 100 mg (Blinded Phase) | Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks. |
| BG001 | Placebo (Blinded Phase) | Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Alkaline Phosphatase (ALP) | Mean | Standard Deviation | units per liter (U/L) |
| |||||||||||||||
| Aspartate Aminotransferase (AST) | Mean | Standard Deviation | U/L |
| |||||||||||||||
| Fasting Total Bile Acids | Participants in the Safety Analysis Set with available data were analyzed. | Mean | Standard Deviation | micromoles per liter (μmol/L) |
| ||||||||||||||
| Enhanced Liver Fibrosis (ELF™) Test Score | The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. | Participants in the Safety Analysis Set with available data were analyzed. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Fibroscan Score | Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. | Participants in the safety analysis set with available data were analyzed. | Mean | Standard Deviation | kilopascals (kPa) |
|
| 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 With Progression of Liver Fibrosis at Blinded Phase Week 96 | Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis). | Full Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants in the Full Analysis Set who had nonmissing data at both baseline and Week 96 in the Blinded Study Phase were analyzed. | Posted | Number | percentage of participants | Blinded Phase Week 96 |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase | An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: 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 and/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 in the Blinded Phase up to 100.3 weeks plus 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced TEAEs in The OLE Phase | An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: 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 and/or any AEs leading to premature discontinuation of study drug. | OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase. | Posted | Number | percentage of participants | First dose date in the OLE Phase up to 45 weeks plus 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase | An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date in the Blinded Phase up to 100.3 weeks plus 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase | An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction. | Participants in the OLE Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date in the OLE Phase up to 45 weeks plus 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | units per liter (U/L) | Baseline, Blinded Phase Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | U/L | Baseline, Blinded Phase Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | micromoles per liter (μmol/L) | Baseline, Blinded Phase Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96 | The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with ≥ 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed. | Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed. | Posted | Number | percentage of participants | Baseline, Blinded Phase Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96 | Fibrosis improvement was defined as having ≥ 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis). | Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed. | Posted | Number | percentage of participants | Blinded Phase Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96 | The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Blinded Phase Week 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96 | The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Blinded Phase Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96 | Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s). | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | kilopascals (kPa) | Baseline, Blinded Phase Week 96 |
|
|
All-cause mortality: Randomization up to 3.4 years; Adverse events: Blinded Phase: First dose date in the Blinded Phase up to 100.3 weeks plus 30 days; Open-Label Extension (OLE) Phase: First dose date in the OLE Phase up to 45 weeks plus 30 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cilofexor 100 mg (Blinded Phase) | Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks. | 2 | 278 | 53 | 277 | 232 | 277 |
| EG001 | Placebo (Blinded Phase) | Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks. | 0 | 141 | 26 | 139 | 109 | 139 |
| EG002 | Cilofexor From Cilofexor 100 mg (OLE Phase) | Participants who received cilofexor in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks. | 0 | 80 | 9 | 80 | 34 | 80 |
| EG003 | Cilofexor From Placebo (OLE Phase) | Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks. | 0 | 45 | 1 | 45 | 24 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pouchitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemorrhagic cholecystitis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatic haematoma | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anaphylactoid reaction | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cholangitis infective | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal procedural complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Endoscopic retrograde cholangiopancreatography | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Marginal zone lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Colorectostomy | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Ligament operation | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Liver transplant | Surgical and medical procedures | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
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 | Aug 10, 2022 | Sep 26, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717094 | cilofexor |
Not provided
Not provided
Not provided
| Adverse Event |
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| Lost to Follow-up |
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| Withdrew consent |
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| Between 18 and 65 years |
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| >=65 years |
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| Japan |
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| United Kingdom |
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| Switzerland |
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| Spain |
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| New Zealand |
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| Canada |
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| Austria |
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| Belgium |
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| Finland |
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| Denmark |
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| Italy |
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| Israel |
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| Australia |
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| France |
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| Germany |
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