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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516525-31-00 | Other Identifier | EU Trial (CTIS) Number |
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To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seladelpar | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seladelpar | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events:
| 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from start of treatment to death from any cause. | 36 months |
| Liver transplant-free survival | Time from start of treatment to the first occurrence of liver-related death or liver transplantation. |
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Inclusion Criteria:
Individuals must meet the following criteria to be eligible for study participation:
Exclusion Criteria:
Individuals must not meet any of the following criteria to be eligible for study participation:
Prior exposure to seladelpar
A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
Decompensated cirrhosis
Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
Hospitalization for liver-related complication within 12 weeks of Screening
Laboratory parameters at Screening:
CP-C cirrhosis
History or presence of other concomitant liver diseases
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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|
| Placebo | Drug | One capsule daily for up to 36 months. |
|
| 36 months |
| Time to hospitalization | Time from start of treatment to the first occurrence of hospitalization for qualifying PBC clinical events | 36 months |
| Time to Event Free Survival (EFS) |
| 36 months |
| St. Joseph's Hospital and Medical Center - 350 W. Thomas |
| Recruiting |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| OM Research LLC | Recruiting | Lancaster | California | 93534 | United States |
| SCPMG/Kaiser Permanente Los Angeles Medical Center | Recruiting | Los Angeles | California | 90027 | United States |
| Cedar Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
| California Liver Research Institute | Recruiting | Pasadena | California | 91105 | United States |
| Stanford University | Recruiting | Redwood City | California | 94063 | United States |
| University of California, Davis Medical Center | Recruiting | Sacramento | California | 95817 | United States |
| California Pacific Medical Center - Sutter Pacific Medical Foundation | Recruiting | San Francisco | California | 94109 | United States |
| Connie Frank Transplant Center at UCSF | Recruiting | San Francisco | California | 94143 | United States |
| Covenant Metabolic Specialists, LLC | Recruiting | Fort Myers | Florida | 33912 | United States |
| Schiff Center for Liver Diseases/University of Miami | Recruiting | Miami | Florida | 33136 | United States |
| Covenant Metabolic Specialists, LLC | Recruiting | Sarasota | Florida | 33912 | United States |
| Florida Research Institute | Recruiting | Tampa | Florida | 34211 | United States |
| Piedmont Atlanta Hospital / Piedmont Transplant Institute | Recruiting | Atlanta | Georgia | 30309 | United States |
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| University Of Iowa Hospitals And Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
| University of Louisville, Clinical Trials Unit | Recruiting | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation | Recruiting | Jefferson | Louisiana | 70121 | United States |
| University Health System - East Jefferson General Hospital Campus | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Mercy Medical Center | Recruiting | Baltimore | Maryland | 21202 | United States |
| Walter Reed National Military | Recruiting | Bethesda | Maryland | 20889 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Henry Ford Medical Center - Columbus | Recruiting | Detroit | Michigan | 48202 | United States |
| University of Rochester Medical Center - Strong Memorial Hospital | Recruiting | Rochester | Minnesota | 14642 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Northwell Health Center for Liver Disease and Transplantation | Recruiting | Manhasset | New York | 11030 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| Wake Forest Baptist Medical Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| University Hosptials Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| The Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| Penn State Health Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania Perelman Center for Advanced Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC Center for Liver Diseases | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| Gastro One | Recruiting | Cordova | Tennessee | 38018 | United States |
| The Liver Institute at Methodist Dallas Medical Center | Recruiting | Dallas | Texas | 75203 | United States |
| University of Texas Southwestern Medical Center, Professional Office Building One | Recruiting | Dallas | Texas | 75390 | United States |
| Soma Clinical Trials | Recruiting | Denison | Texas | 75020 | United States |
| American Research Corporation | Recruiting | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research, PLLC | Recruiting | San Antonio | Texas | 78229 | United States |
| MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax | Recruiting | Fairfax | Virginia | 22031 | United States |
| Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads | Recruiting | Newport News | Virginia | 23602 | United States |
| VCU Health Clinical Research Services Unit (CRSU) | Recruiting | Richmond | Virginia | 23298 | United States |
| Liver Institute Northwest | Recruiting | Seattle | Washington | 98105 | United States |
| Hospital Italiano de Buenos Aires | Recruiting | Buenos Aires | 1181 | Argentina |
| Consultorios Médicos Dr. Doreski - PPDS | Recruiting | Buenos Aires | 1426 | Argentina |
| Buenos Aires Mácula | Recruiting | Buenos Aires | C1061 | Argentina |
| Centro de Investigación y Prevención Cardiovascular | Recruiting | Buenos Aires | C1061 | Argentina |
| AES - AS - Glenny Corp. S.A. Buenos Aires | Recruiting | Buenos Aires | C1430 | Argentina |
| Higea S.A. | Recruiting | Mendoza | M5500 | Argentina |
| DIM Clinica Privada | Recruiting | Ramos Mejía | 1704 | Argentina |
| CINME S.A. - Centro de Investigaciones Metabólicas | Recruiting | Recoleta | C1118AAT | Argentina |
| Hospital Provincial Del Centenario | Recruiting | Rosario | 2000 | Argentina |
| Princess Alexandra Hospital | Recruiting | Queensland | Queensland | 4102 | Australia |
| Flinders Medical Center | Recruiting | Adelaide | South Australia | 5042 | Australia |
| Monash Health, Monash Medical Centre | Recruiting | Clayton | Victoria | 3168 | Australia |
| Northern Health | Recruiting | Epping | Victoria | 3076 | Australia |
| Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Landeskrankenhaus Hall | Recruiting | Hall in Tirol | 6060 | Austria |
| Krankenhaus der Barmherzigen Brüder | Recruiting | Vienna | 1020 | Austria |
| Medizinische Universität Wien | Recruiting | Vienna | 1090 | Austria |
| Klinikum Wels-Grieskirchen GmbH - Standort Wels | Recruiting | Wels | 4600 | Austria |
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
| UZ Leuven - PPDS | Recruiting | Leuven | 3000 | Belgium |
| University of Calgary | Recruiting | Calgary | T2N 4Z6 | Canada |
| University of Alberta | Recruiting | Edmonton | T6G 2B7 | Canada |
| Centre Hospitalier de l'Universite de Montreal | Recruiting | Montreal | H2L 4M1 | Canada |
| Ottawa Hospital | Recruiting | Ottawa | K1H 8L6 | Canada |
| Diex Recherche - Québec - PPDS | Recruiting | Québec | G1V 4T3 | Canada |
| Toronto General Hospital | Recruiting | Toronto | M5G 2C4 | Canada |
| GI Research Institute Foundation | Recruiting | Vancouver | V6G 2Z6 | Canada |
| Centro de Investigación y Prevención Cardiovascular | Recruiting | La Serena | 1720506 | Chile |
| Pontificia Universidad Católica de Chile | Recruiting | Santiago | 8320000 | Chile |
| BIOCINETIC Ltda | Recruiting | Santiago | 8330336 | Chile |
| Clinical Research Chile SpA - PPDS | Recruiting | Valdivia | 5110683 | Chile |
| Beijing Youan Hospital, Capital Medical University | Recruiting | Beijing | 100000 | China |
| Beijing Ditan Hospital, Capital Medical University | Recruiting | Beijing | 100015 | China |
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | 100050 | China |
| The First Hospital of Jilin University | Recruiting | Changchun | 130021 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | 610047 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | 401336 | China |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Recruiting | Fuzhou | China |
| The Third Affiliated Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | 510630 | China |
| Guizhou Provincial People's Hospital | Recruiting | Guiyang | 550002 | China |
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | 230032 | China |
| The First People's Hospital of Yunnan Province | Recruiting | Kunming | 650032 | China |
| The Second Hospital of Nanjing | Recruiting | Nanjing | 210003 | China |
| Shanghai Jiaotong University School of Medicine, Renji Hospital | Recruiting | Shanghai | 200001 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | 830054 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | 430030 | China |
| The First Affiliated Hospital of PLA Air Force Medical University | Recruiting | Xi'an | 710032 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | 710061 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Zhejiang | 310009 | China |
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | 450003 | China |
| The Third People's Hospital of Zhenjiang | Recruiting | Zhenjiang | 212021 | China |
| Fakultni nemocnice Ostrava | Recruiting | Ostrava | 70852 | Czechia |
| RESEARCH Site s.r.o | Recruiting | Pilsen | 301 00 | Czechia |
| Aarhus Universitetshospital | Recruiting | Aarhus | 8200 | Denmark |
| AP-HP - Hopital Avicenne | Recruiting | Bobigny | 93000 | France |
| Hôpital Claude Huriez-Lille-1 Place de Verdun | Recruiting | Lille | 59000 | France |
| Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse | Recruiting | Lyon | 69317 | France |
| CHU-Montpellier-Hopital St Eloi | Recruiting | Montipellier | 34295 | France |
| Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris | Recruiting | Paris | 75012 | France |
| AP-HP Hopital Henri Mondor | Recruiting | Paris | 94000 | France |
| CHU de Strasbourg - Nouvel Hôpital Civil | Recruiting | Strasbourg | 67000 | France |
| CHRU de Nancy - Hôpitaux de Brabois | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
| Charité Campus Virchow-Klinikum-Augustenburger Platz 1 | Recruiting | Berlin | 13353 | Germany |
| Universitatsklinikum des Saarlandes | Recruiting | Homburg | 66421 | Germany |
| Gastroenterologisch - Hepatologisches MVZ Kiel GmbH | Recruiting | Kiel | 24146 | Germany |
| Evangelismos General Hospital | Recruiting | Athens | 106 76 | Greece |
| University General Hospital of Larissa | Recruiting | Larissa | 41 110 | Greece |
| General Hospital of Thessaloniki ''Hippokratio'' | Recruiting | Thessaloniki | 546 41 | Greece |
| Prince of Wales Hospital - Hong Kong | Recruiting | Hong Kong | 000 | Hong Kong |
| Queen Mary Hospital - PPDS | Recruiting | Hong Kong | 999077 | Hong Kong |
| Princess Margaret Hospital - Hong Kong | Recruiting | Hong Kong | Hong Kong |
| Semmelweis Egyetem - Sebészeti, | Recruiting | Budapest | 1082 | Hungary |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz | Recruiting | Kaposvár | 7400 | Hungary |
| Soroka University Medical Centre | Recruiting | Beersheba | 84101 | Israel |
| Lady Davis Carmel Medical Center | Recruiting | Haifa | 33394 | Israel |
| Liver Unit, institute of Gasteroenterology and Liver Diseases | Recruiting | Jerusalem | 91120 | Israel |
| Rambam Health Care Campus - PPDS | Recruiting | Ramat Gan | 52394 | Israel |
| The Chaim Sheba Medical Center - PPDS | Recruiting | Ramat Gan | 5266202 | Israel |
| Tel Aviv Sourasky Medical Center Ichilov | Recruiting | Tel Aviv | 64239 | Israel |
| Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi | Recruiting | Ancona | 60020 | Italy |
| IRCCS Saverio de Bellis-UOSD "Epatopatie" | Recruiting | Castellana Grotte | 70013 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico | Recruiting | Milan | 20142 | Italy |
| Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara | Recruiting | Modena | 41126 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori | Recruiting | Monza | 20052 | Italy |
| Azienda Ospedale - Università Padova | Recruiting | Padova | 35100 | Italy |
| A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia | Recruiting | Palermo | 90127 | Italy |
| A.O.U. Pisana, U.O. Epatologia | Recruiting | Pisa | 56124 | Italy |
| Ospedale Casa Sollievo Della Sofferenza IRCCS | Recruiting | San Giovanni Rotondo | 71013 | Italy |
| Clinica de Higado y Gastroenterologia Integral, S.C. | Recruiting | Cuernavaca | 62170 | Mexico |
| PROACTIVE CR MEXICO SA de CV | Recruiting | Irapuato | 36650 | Mexico |
| Consultorio Medico - Distrito Federal | Recruiting | Mexico City | 6700 | Mexico |
| Centro De Investigacion Y Gastroenterogia, S.C. | Recruiting | México | 76806 | Mexico |
| Oaxaca Site Management Organization - Hospital - OSMO - PPDS | Recruiting | Oaxaca City | 71256 | Mexico |
| FAICIC | Recruiting | Veracruz | 91900 | Mexico |
| ID Clinic Arkadiusz Pisula | Recruiting | Mysłowice | 41-400 | Poland |
| PlanetMed SP. z. o. o | Recruiting | Wroclaw | 52-210 | Poland |
| Galenus Group - Puerto Rico | Recruiting | Manati | 00674 | Puerto Rico |
| Institutul Clinic Fundeni | Recruiting | Bucharest | 022328 | Romania |
| National University Hospital | Recruiting | Singapore | 119228 | Singapore |
| Singapore General Hospital (SGH) | Recruiting | Singapore | 308433 | Singapore |
| Tan Tock Seng Hospital | Recruiting | Singapore | 308433 | Singapore |
| Changi General Hospital | Recruiting | Singapore | 529889 | Singapore |
| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
| Kyungpook National University Hospital | Recruiting | Daegu | 41944 | South Korea |
| Chonnam National University Hospital | Recruiting | Gwangju | 61455 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam | 13620 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 3722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 6351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | 6591 | South Korea |
| Complexo Hospitalario Universitario De Santiago | Recruiting | A Coruña | 15706 | Spain |
| Hospital Universitario Fundacion Alcorcon | Recruiting | Alcorcón | 28925 | Spain |
| Hospital Universitario Germans Trias i Pujol | Recruiting | Badalona | 08916 | Spain |
| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
| Hospital Universitario Vall d'Hebron-VIHR | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| C.H. Regional Reina Sofia - PPDS | Recruiting | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Marques de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Recruiting | Seville | 41010 | Spain |
| Universitätsspital Bern | Recruiting | Bern | 3010 | Switzerland |
| Universitätsspital Zürich | Recruiting | Zurich | 8091 | Switzerland |
| Chiayi Christian Hospital | Recruiting | Chiayi City | Taiwan |
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | 80756 | Taiwan |
| Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 83301 | Taiwan |
| National Cheng Kung University Hospital | Recruiting | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Recruiting | Taoyuan | 33305 | Taiwan |
| Adana City Training and Research Hospital | Recruiting | Adana | 1370 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital | Recruiting | Gaziantep | 27630 | Turkey (Türkiye) |
| Uludag University Medical Faculty | Recruiting | Görükle | 16059 | Turkey (Türkiye) |
| Ege University | Recruiting | Izmir | 35040 | Turkey (Türkiye) |
| Katip Celebi University | Recruiting | Karabağlar | 35150 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty Hospital | Recruiting | Kocaeli | 41380 | Turkey (Türkiye) |
| Mersin Universitesi Tip Fakultesi Hastanesi | Recruiting | Mersin | 33110 | Turkey (Türkiye) |
| Marmara University Pendik Training and Research Hospital | Recruiting | Pendik | 34899 | Turkey (Türkiye) |
| Rize Recep Tayyip Erdogan University Training and Research Hospital | Recruiting | Rize Merkez | 53020 | Turkey (Türkiye) |
| Hull Royal Infirmary | Recruiting | Hull | HU32JZ | United Kingdom |
| East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital | Recruiting | Ipswich | IP4 5PD | United Kingdom |
| St James's University Hospital - PPDS | Recruiting | Leeds | LS9 7TF | United Kingdom |
| The Royal London Hospital | Recruiting | London | E1 1BB | United Kingdom |
| Royal Free Hospital | Recruiting | London | NW2 2QG | United Kingdom |
| King's College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
| Freeman Hospital | Recruiting | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| John Radcliffe Hospital | Recruiting | Oxford | OX3 9DU | United Kingdom |
| Sheffield teaching hospital NHS foundation trust | Recruiting | Sheffield | S10 2JF | United Kingdom |
| New Cross Hospital | Recruiting | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000713688 | seladelpar |
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