Back to resultsENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Primary Purpose
Primary Biliary Cholangitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
seladelpar 5-10 mg
seladelpar 10 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring PBC, Primary Biliary Cholangitis (PBC)
Eligibility Criteria
Inclusion Criteria:
- Must have given written informed consent (signed and dated) and any authorizations required by local law
- 18 to 75 years old (inclusive)
Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
- On a stable and recommended dose of UDCA for the past twelve months OR intolerant to UDCA (last dose of UDCA > 3 months prior to Screening)
- AP ≥ 1.67 × ULN
- Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Exclusion Criteria:
- Previous exposure to seladelpar (MBX-8025)
- A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
- AST above 3 × ULN
- ALT above 3 × ULN
- Total bilirubin above 2.0 × ULN
- Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total bilirubin above 1 × ULN)
- Creatine kinase (CK) above 1.0 × ULN
- eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
- International normalized ratio (INR) above 1.0 × ULN
- Platelet count below 100 × 103/µL
Presence of clinically significant hepatic decompensation, including:
- History of liver transplantation, current placement on liver transplantation list, or current MELD score ≥ 15
- Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (e.g., transjugular intrahepatic portosystemic shunt placement), relevant ascites, hepatic encephalopathy
- Cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis
Other chronic liver diseases:
- Current features of auto-immune hepatitis as determined by the investigator based on immunoserology, liver biochemistry and histology
- Primary sclerosing cholangitis determined by presence of diagnostic cholangiographic findings
- History or clinical evidence of alcoholic liver disease
- History or clinical evidence of alpha-1-antitrypsin deficiency
- Biopsy confirmed nonalcoholic steatohepatitis
- History or evidence of Gilbert' Syndrome with elevated total bilirubin
- History or evidence of hemochromatosis
- Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C defined as presence of HCV RNA
- Known history of HIV
- Evidence of significant alcohol consumption
- Evidence of drug abuse
- Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA must be discontinued 30 days prior to Screening
- Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (> 2 weeks) within two months prior to Screening
- Use of fibrates within 30 days prior to Screening
- Use of simvastatin within 7 days prior to Screening
- Use of an experimental or unapproved treatment for PBC within 30 days prior to Screening
- Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
- Treatment with any other investigational therapy or device within 30 days or within five half-lives, whatever is longer, prior to Screening
- For females, pregnancy or breast-feeding
- Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator
Sites / Locations
- Institute for Liver Health
- Mayo Clinic Arizona - PPDS
- The Institute for Liver Health-Tucson
- Cedars Sinai Medical Center
- Stanford University School of Medicine
- University of California Davis Medical Center
- California Pacific Medical Center
- Univeristy of Colorado Denver and Hospital
- Yale School of Medicine Digestive Diseases, Internal Medicine
- Excel Medical Clinical Trials, LLC
- Florida Reserach Institute
- Schiff Center for Liver Diseases University of Miami
- Tampa General Medical Group
- Digestive Healthcare of Georgia
- University of Chicago Medical Center
- Indianapolis Gastroenterology Research Foundation
- University of Kansas Hospital
- Tulane University School of Medicine
- Beth Israel Deaconess Medical Center
- Massachusetts General Hospital
- Henry Ford Health System
- Minnesota Gastroenterlogy, P.A.
- University of Minnesota Medical Center, Fairview
- Southern Therapy and Advance Research (STAR) LLC
- Digestive Health Specialists PA
- Kansas City Research Institute
- Concorde Medical Group
- NYU Langone Health
- Icahn School of Medicine at Mount Sinai
- Center for Liver Disease and Transplantation
- University of Rochester Medical Center
- Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A.
- Duke University Medical Center
- UH Cleveland Medical Center
- Northeast Clinical Research Center, LLC
- Penn State Milton S Hershey Medical Center
- University of Pittsburgh Medical Center
- Gastro One
- GIA Clinical Trials, LLC
- Vanderbilt University Medical Center
- Liver Institute at Methodist Dallas
- University of Texas Southwestern Medical Center
- Texas Digestive Disease Consultants
- American Research Corporation
- Baylor College of Medicine
- American Research Corporation at Texas Liver Institute
- Pinnacle Clinical Research
- Intermountain Medical Center
- Mary Immaculate Hospital
- Bon Secours Richmond Community Hospital
- Swedish Medical Center
- Hospital Universitario Austral
- Fundación Sanatorio Güemes
- Hospital Provincial Del Centenario
- DIM Clínica Privada
- The Canberra Hospital
- Royal Brisbane & Women's Hospital
- St Vincents Hospital Melbourne
- Royal Melbourne Hospital
- Royal Perth Hospital
- Medizinische Universitat Wien
- LKH-Universitätsklinikum Klinikum Graz
- Salzburger Landeskliniken
- Klinikum Wels-Grieskirchen GmbH
- UZ Antwerpen
- UZ Gent
- UZ Leuven
- University of Calgary Medicine
- University of Manitoba
- University Health Network
- Toronto Digestive Disease Associates Inc
- McGill University Health Centre (MUHC)
- Pontificia Universidad Catolica de Chile
- Centro Clinico Mediterraneo
- Centro de Investigaciones Clínicas Vina del Mar
- Hôpital Jean Verdier
- CHU de GRENOBLE
- Hôpital Saint Antoine
- Universitätsklinikum Tübingen
- Gastroenterologische Gemeinschaftspraxis Herne
- Uniklinik Köln
- Gastroenterologisch Hepatologisches Zentrum Kiel
- Charité - Universitätsmedizin Berlin
- Universitätsklinikum Erlangen
- ifi-Institute for Interdisciplinary Medicine
- Universitatsklinikum Leipzig
- University General Hospital of Heraklion
- University General Hospital of Larissa
- University General Hospital of Patras
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
- Budai Hepatológiai Centrum
- Debreceni Egyetem Klinikai Kozpont
- Somogy Megyei Kaposi Mór Oktató Kórház
- Hillel Yaffe Medical Center
- Carmel Medical Center
- Rambam Health Corporation
- Hadassah Medical Center
- The Galilli Medical Center
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center
- Azienda Ospedaliera Universitaria Careggi
- ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
- Ospedale Civile di Baggiovara
- Azienda Ospedaliera Di Padova
- ASST di Monza - Azienda Ospedaliera San Gerardo
- Seoul National University Bundang Hospital
- Pusan National University Hospital
- Kyungpook National University Hospital
- Seoul National University Hospital
- Inje University Ilsan Paik Hospital
- Gangnam Severance Hospital, Yonsei University Health System
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Severance Hospital Yonsei University Health System
- Centro de Diabetes y Obesidad Graber
- Consultorio Medico - Distrito Federal
- Consultorio de la Doctora Maria Sarai Gonzalez Huezo
- Radboud Universitair Medisch Centrum
- Christchurch Hospital
- Dunedin Hospital
- Waikato Hospital
- Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
- Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
- Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
- Wojewodzki Szpital Zespolony w Kielcach
- SP ZOZ Szpital Uniwersytecki w Krakowie
- ID Clinic
- Pius Brinzeu Emergency Clinical County Hospital
- Colentina Clinical Hospital
- Fundeni Clinical Institute
- Sana Monitoring SRL
- Peoples Friendship University of Russia
- City Hospital #31
- Ulyanovsk Regional Clinical Hospital
- Clinical Hospital Centar Zvezdara
- KBC Zemun
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital Universitario Vall d'Hebrón - PPDS
- Hospital Clinic de Barcelona
- Hospital Universitario Germans Trias i Pujol
- Hospital Universitario Ramon y Cajal
- Hospital Universitario La Paz
- Hospital Universitario Virgen de la Victoria
- Hospital Universitario Virgen del Rocio
- Hospital Clinico Universitario de Valencia
- Hospital Universitari i Politecnic La Fe de Valencia
- Queen Alexandra Hospital
- University Hospital Birmingham
- Hull and East Yorkshire Hospitals NHS Trust
- Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
- Royal Free London NHS Foundation Trust
- Kings College Hospital
- The Newcastle Upon Tyne Hospital NHS Foundation Trust
- University of Nottingham
- Plymouth Hospitals NHS Trust
- Singleton Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Seladelpar 5-10 mg
Seladelpar 10 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3
Percentage of Participants with Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% reduction in ALP, and total bilirubin ≤ ULN) at Month 3. The mITT analysis set included all randomized subjects who received at least one study drug dose.
The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: <350 U/L and 2:350 U/L; pruritus NRS: <4 and 2:4). The CMH tests were performed for the comparison of 10 mg versus placebo and 5 mg/10 mg versus placebo separately.
Secondary Outcome Measures
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3
The response was defined by normalized ALP levels (ALP ≤1.0 × ULN) at endpoint. The mITT analysis set included all randomized subjects who received at least one study drug dose.
Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3
Pruritus Numerical Rating Scale (NRS) used to rate the intensity of the worst itching you experienced in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching. The analysis will be limited to those subjects in the mITT analysis set with a baseline NRS ≥ 4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03602560
Brief Title
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Official Title
A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 16, 2020 (Actual)
Study Completion Date
February 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CymaBay Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Detailed Description
Primary:
To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placebo
Key Secondary:
To evaluate the effect of seladelpar on normalization of alkaline phosphatase (AP) levels
To evaluate the effect of seladelpar on pruritus
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis
Keywords
PBC, Primary Biliary Cholangitis (PBC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
265 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seladelpar 5-10 mg
Arm Type
Experimental
Arm Title
Seladelpar 10 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
seladelpar 5-10 mg
Intervention Description
Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study
Intervention Type
Drug
Intervention Name(s)
seladelpar 10 mg
Intervention Description
Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3
Description
Percentage of Participants with Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% reduction in ALP, and total bilirubin ≤ ULN) at Month 3. The mITT analysis set included all randomized subjects who received at least one study drug dose.
The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: <350 U/L and 2:350 U/L; pruritus NRS: <4 and 2:4). The CMH tests were performed for the comparison of 10 mg versus placebo and 5 mg/10 mg versus placebo separately.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3
Description
The response was defined by normalized ALP levels (ALP ≤1.0 × ULN) at endpoint. The mITT analysis set included all randomized subjects who received at least one study drug dose.
Time Frame
Month 3
Title
Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3
Description
Pruritus Numerical Rating Scale (NRS) used to rate the intensity of the worst itching you experienced in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching. The analysis will be limited to those subjects in the mITT analysis set with a baseline NRS ≥ 4.
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have given written informed consent (signed and dated) and any authorizations required by local law
18 to 75 years old (inclusive)
Male or female with a diagnosis of PBC, by at least two of the following criteria:
History of AP above ULN for at least six months
Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive PBC-specific antinuclear antibodies
Documented liver biopsy result consistent with PBC
On a stable and recommended dose of UDCA for the past twelve months OR intolerant to UDCA (last dose of UDCA > 3 months prior to Screening)
AP ≥ 1.67 × ULN
Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Exclusion Criteria:
Previous exposure to seladelpar (MBX-8025)
A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
AST above 3 × ULN
ALT above 3 × ULN
Total bilirubin above 2.0 × ULN
Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total bilirubin above 1 × ULN)
Creatine kinase (CK) above 1.0 × ULN
eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
International normalized ratio (INR) above 1.0 × ULN
Platelet count below 100 × 103/µL
Presence of clinically significant hepatic decompensation, including:
History of liver transplantation, current placement on liver transplantation list, or current MELD score ≥ 15
Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (e.g., transjugular intrahepatic portosystemic shunt placement), relevant ascites, hepatic encephalopathy
Cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis
Other chronic liver diseases:
Current features of auto-immune hepatitis as determined by the investigator based on immunoserology, liver biochemistry and histology
Primary sclerosing cholangitis determined by presence of diagnostic cholangiographic findings
History or clinical evidence of alcoholic liver disease
History or clinical evidence of alpha-1-antitrypsin deficiency
Biopsy confirmed nonalcoholic steatohepatitis
History or evidence of Gilbert' Syndrome with elevated total bilirubin
History or evidence of hemochromatosis
Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
Hepatitis C defined as presence of HCV RNA
Known history of HIV
Evidence of significant alcohol consumption
Evidence of drug abuse
Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA must be discontinued 30 days prior to Screening
Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (> 2 weeks) within two months prior to Screening
Use of fibrates within 30 days prior to Screening
Use of simvastatin within 7 days prior to Screening
Use of an experimental or unapproved treatment for PBC within 30 days prior to Screening
Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
Treatment with any other investigational therapy or device within 30 days or within five half-lives, whatever is longer, prior to Screening
For females, pregnancy or breast-feeding
Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator
Facility Information:
Facility Name
Institute for Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Mayo Clinic Arizona - PPDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
The Institute for Liver Health-Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University School of Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Univeristy of Colorado Denver and Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale School of Medicine Digestive Diseases, Internal Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Excel Medical Clinical Trials, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Florida Reserach Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Schiff Center for Liver Diseases University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Tampa General Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Minnesota Gastroenterlogy, P.A.
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55117
Country
United States
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Southern Therapy and Advance Research (STAR) LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Digestive Health Specialists PA
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Center for Liver Disease and Transplantation
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UH Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
GIA Clinical Trials, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Liver Institute at Methodist Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
American Research Corporation
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Research Corporation at Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Mary Immaculate Hospital
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Bon Secours Richmond Community Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Hospital Universitario Austral
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Facility Name
Fundación Sanatorio Güemes
City
Buenos Aires
State/Province
Ciudad Autónoma De BuenosAires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Hospital Provincial Del Centenario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KDS
Country
Argentina
Facility Name
DIM Clínica Privada
City
Ramos Mejía
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Medizinische Universitat Wien
City
Vienna
State/Province
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
LKH-Universitätsklinikum Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Salzburger Landeskliniken
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Calgary Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
McGill University Health Centre (MUHC)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Pontificia Universidad Catolica de Chile
City
Santiago
State/Province
Región-MetropolitanadeSantiago
ZIP/Postal Code
8330034
Country
Chile
Facility Name
Centro Clinico Mediterraneo
City
La Serena
ZIP/Postal Code
1720506
Country
Chile
Facility Name
Centro de Investigaciones Clínicas Vina del Mar
City
Viña Del Mar
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Hôpital Jean Verdier
City
Bondy
ZIP/Postal Code
93140
Country
France
Facility Name
CHU de GRENOBLE
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Herne
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44623
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Gastroenterologisch Hepatologisches Zentrum Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24146
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
ifi-Institute for Interdisciplinary Medicine
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University General Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Budai Hepatológiai Centrum
City
Budapest
ZIP/Postal Code
1111
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
The Galilli Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52662
Country
Israel
Facility Name
Kaplan Medical Center
City
Reẖovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Ospedale Civile di Baggiovara
City
Modena
ZIP/Postal Code
41126
Country
Italy
Facility Name
Azienda Ospedaliera Di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
ASST di Monza - Azienda Ospedaliera San Gerardo
City
Rozzano
ZIP/Postal Code
20090
Country
Italy
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137 701
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
Centro de Diabetes y Obesidad Graber
City
Pachuca de Soto
State/Province
Hidalgo
ZIP/Postal Code
42086
Country
Mexico
Facility Name
Consultorio Medico - Distrito Federal
City
Ciudad de Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
City
Metepec
ZIP/Postal Code
52140
Country
Mexico
Facility Name
Radboud Universitair Medisch Centrum
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
South Island
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
State/Province
South Island
ZIP/Postal Code
9001
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony w Kielcach
City
Kielce
ZIP/Postal Code
25-317
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
31-531
Country
Poland
Facility Name
ID Clinic
City
Mysłowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Pius Brinzeu Emergency Clinical County Hospital
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300723
Country
Romania
Facility Name
Colentina Clinical Hospital
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Sana Monitoring SRL
City
Bucharest
Country
Romania
Facility Name
Peoples Friendship University of Russia
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
City Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Clinical Hospital Centar Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
KBC Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Queen Alexandra Hospital
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
University Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospital NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
We'll reach out to this number within 24 hrs