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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Primary Purpose

Primary Biliary Cirrhosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seladelpar 5 mg Capsule
Seladelpar 10 mg Capsule
Sponsored by
CymaBay Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring PBC, Primary Biliary Cholangitis (PBC)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must have given written informed consent (signed and dated)
  2. Participated in a PBC study with seladelpar
  3. 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:

Exclusion criteria are only applicable for subjects with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption.

  1. Treatment-related adverse event (AE) leading to seladelpar discontinuation in a previous PBC study with seladelpar (MBX-8025)
  2. 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)
  3. AST or ALT above 3 × the upper limit of normal (ULN)
  4. Total bilirubin above 2 × ULN
  5. MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
  6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
  7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
  8. Auto-immune hepatitis
  9. Primary sclerosing cholangitis
  10. Known history of alpha-1-antitrypsin deficiency
  11. Known history of chronic viral hepatitis
  12. For females, pregnancy or breast-feeding
  13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
  14. Current use of fibrates or use of fibrates within 3 months prior to Screening
  15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
  16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
  17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
  18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
  19. 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
  20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
  21. Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis

  22. Positive for:

    1. Hepatitis B, defined as the presence of hepatitis B surface antigen
    2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
    3. Human immunodeficiency virus (HIV) antibody
  23. Active COVID-19 infection during screening

Sites / Locations

  • Arkansas Diagnostic CentreRecruiting
  • Stanford University School of MedicineRecruiting
  • California Liver Research InstituteRecruiting
  • University of California, Davis Medical CenterRecruiting
  • California Pacific Medical Center- Sutter Pacific Medical FoundationRecruiting
  • University of ColoradoRecruiting
  • Yale School of MedicineRecruiting
  • Covenant Metabolic Specialist LLCRecruiting
  • Florida Digestive Health SpecialistRecruiting
  • Schiff Center for Liver Diseases/University of MiamiRecruiting
  • Covenant Metabolic Specialist LLCRecruiting
  • Digestive Healthcare of GeorgiaRecruiting
  • The University of Chicago Institutional Review BoardRecruiting
  • Tulane Medical CenterRecruiting
  • Mercy Medical CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Henry Ford Health SystemRecruiting
  • MNGI Digestive Health, P.A.Recruiting
  • Southern Therapy and Advanced Research (STAR), LLCRecruiting
  • Saint Louis UniversityRecruiting
  • Northwell Health Center for Liver DiseasesRecruiting
  • NYU Langone HealthRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • University of Rochester Medical Center - PPDSRecruiting
  • Duke University Medical CenterRecruiting
  • Northeast Clinical Research Center, LLCRecruiting
  • Penn State Milton S Hershey Medical CenterRecruiting
  • UPMC Center for Liver DiseasesRecruiting
  • Galen HepatologyRecruiting
  • Gastro OneRecruiting
  • Vanderbilt Hepatology and Liver TransplantRecruiting
  • The Liver Institute at Methodist Dallas Medical CenterRecruiting
  • U.T. Southwestern Medical Center Investigation Drug ServiceRecruiting
  • Baylor College of MedicineRecruiting
  • American Research Corporation at the Texas Liver InstituteRecruiting
  • Pinnacle Clinical Research, PLLCRecruiting
  • Maryview Hospital IncRecruiting
  • Richmond Community Hospital LLC., d/b/a Bon Secours Liver Institute of RichmondRecruiting
  • Liver Institute NorthwestRecruiting
  • CINME (Centro de Investigaciones MetabolicasRecruiting
  • Hospital Italiano de Buenos AriesRecruiting
  • DIM Clinica PrivadaRecruiting
  • Hospital Italiano de la PlataRecruiting
  • Royal Brisbane & Women's HospitalRecruiting
  • Alfred HospitalRecruiting
  • Royal Melbourne HospitalRecruiting
  • Klinikum Wels-Grieskirchen GmbHRecruiting
  • UZ GentRecruiting
  • UZ LeuvenRecruiting
  • University of Calgary MedicineRecruiting
  • Toronto General HospitalRecruiting
  • Centro Clinico MediterraneoRecruiting
  • Interni a Kardiologicka Klinika-Oddeleni Gastroenterologie a HepatologieRecruiting
  • Hopital de la Croix-RousseRecruiting
  • Hôpital Saint AntoineRecruiting
  • Universitatsklinik Tubingen, Medizinische Klinik, Innere Medizin IRecruiting
  • Universitatsklinikum Erlangen, Medizinische Klink I, GastroenterologieRecruiting
  • Gastroenterologische GemeinschaftspraxisRecruiting
  • Gastroenterologisch - Hepatologisches Zentrum KielRecruiting
  • Charite Universitatsmedizin Berlin, Medizinische PoliklinikRecruiting
  • Ifi-Medizin GmbHRecruiting
  • General University Hospital of Larissa Department of Medicine and Research Laboratory of Internal MedicineRecruiting
  • Semmelweis EgyetemRecruiting
  • Somogy Megyei Kaposi Mor Oktato KorhazRecruiting
  • Carmel Medical CenterRecruiting
  • Hadassah Medical Center - PPDSRecruiting
  • Liver Disease Center, Sheba Medical CenterRecruiting
  • Tel Aviv Sourasky Medical Center PPDSRecruiting
  • ASST di MonzaRecruiting
  • Nuovo Ospedale Civile S. Agostino-Estense di BaggiovaraRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Paolo GiacconeRecruiting
  • Soon Chun Hyang University Hospital BucheonRecruiting
  • Asan Medical CentreRecruiting
  • Inje University Busan Paik HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Consultorio Medico - Distrito FederalRecruiting
  • Consultorio de la Doctora Maria Sarai Gonzalez HuezoRecruiting
  • Radboudumc/Research Unit MDLRecruiting
  • Christchurch HospitalRecruiting
  • Dunedin HospitalRecruiting
  • Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Gastroenterologii i HepatologiiRecruiting
  • ID Clinic Arkadiusz PisulaRecruiting
  • Fundeni Clinical InstituteRecruiting
  • Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies
  • SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov
  • Federal state budget educational institution of high education "Stavropol state medical university"
  • Ulyanovsk Regional Clinical Hospital
  • Hospital Universitario Germans Trias i PujolRecruiting
  • Hospital clinic De BarcelonaRecruiting
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital Universitario Vall D'HebronRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Ankara Gazi University Faculty of Medicine HospitalRecruiting
  • Ankara Sehir Hastanesi, Universiteler MahallesiRecruiting
  • Ege University Medical Faculty, Kazimdirik MahRecruiting
  • Derriford HospitalRecruiting
  • Portsmouth Hospitals University NHS TrustRecruiting
  • Queen's Medical CentreRecruiting
  • Queen Elizabeth Hospital BirminghamRecruiting
  • University Hospital Birmingham - Queen Elizabeth HospitalRecruiting
  • Hull University Teaching Hospitals NHS TrustRecruiting
  • Barts Health NHS TrustRecruiting
  • Kings College HospitalRecruiting
  • The Newcastle Upon Tyne Hospital NHS Foundation TrustRecruiting
  • The Newcastle Upon Tyne Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Seladelpar 5 mg Capsules

Seladelpar 10 mg Capsule

Arm Description

Outcomes

Primary Outcome Measures

Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results

Secondary Outcome Measures

Death
Occurrence of overall death
Liver transplantation
Occurrence of overall liver transplantation
Change in MELD
MELD score ≥ 15 for at least 2 consecutive visits
Ascites
Occurrence of overall ascites requiring treatment
Hospitalization for variceal bleeding
Hospitalization for new onset, or recurrence, of variceal bleeding
Hospitalization for hepatic encephalopathy
Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)
Hospitalization for spontaneous bacterial peritonitis
Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
Response on composite endpoint
Alkaline phosphate (ALP)
Response on composite endpoint
Total bilirubin
Normalization of ALP
Proportion of subjects with normalization of ALP
Laboratory Value: Serum Alkaline Phosphatase (ALP)
Serum Alkaline Phosphatase (ALP)
Laboratory Value: Aspartate Aminotransferase (AST)
Aspartate Aminotransferase (AST)
Laboratory Value: Alanine Aminotransferase (ALT)
Alanine Aminotransferase (ALT)
Laboratory Value: Gamma-glutamyl Transferase (GGT)
Gamma-glutamyl Transferase (GGT)
Laboratory Value: Bilirubin - Total Bilirubin
Bilirubin - Total Bilirubin
Laboratory Value: Bilirubin - Conjugated Bilirubin
Bilirubin - Conjugated Bilirubin
Laboratory Value: Bilirubin - Unconjugated Bilirubin
Bilirubin - Unconjugated Bilirubin

Full Information

First Posted
September 26, 2017
Last Updated
August 28, 2023
Sponsor
CymaBay Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03301506
Brief Title
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Official Title
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

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
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Detailed Description
Primary: To evaluate the long-term safety and tolerability of seladelpar Secondary: To evaluate the long-term efficacy of seladelpar To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
PBC, Primary Biliary Cholangitis (PBC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Seladelpar 5 mg Capsules
Arm Type
Experimental
Arm Title
Seladelpar 10 mg Capsule
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Seladelpar 5 mg Capsule
Other Intervention Name(s)
MBX-8025
Intervention Description
Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.
Intervention Type
Drug
Intervention Name(s)
Seladelpar 10 mg Capsule
Other Intervention Name(s)
MBX-8025
Intervention Description
Subjects will be assigned to a treatment group unless there are tolerability issues.
Primary Outcome Measure Information:
Title
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
Time Frame
Through study completion, up to 60 Months
Secondary Outcome Measure Information:
Title
Death
Description
Occurrence of overall death
Time Frame
60 Months
Title
Liver transplantation
Description
Occurrence of overall liver transplantation
Time Frame
60 Months
Title
Change in MELD
Description
MELD score ≥ 15 for at least 2 consecutive visits
Time Frame
60 Months
Title
Ascites
Description
Occurrence of overall ascites requiring treatment
Time Frame
60 Months
Title
Hospitalization for variceal bleeding
Description
Hospitalization for new onset, or recurrence, of variceal bleeding
Time Frame
60 Months
Title
Hospitalization for hepatic encephalopathy
Description
Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)
Time Frame
60 Months
Title
Hospitalization for spontaneous bacterial peritonitis
Description
Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
Time Frame
60 Months
Title
Response on composite endpoint
Description
Alkaline phosphate (ALP)
Time Frame
60 Months
Title
Response on composite endpoint
Description
Total bilirubin
Time Frame
60 Months
Title
Normalization of ALP
Description
Proportion of subjects with normalization of ALP
Time Frame
60 Months
Title
Laboratory Value: Serum Alkaline Phosphatase (ALP)
Description
Serum Alkaline Phosphatase (ALP)
Time Frame
Through study completion, up to 60 Months
Title
Laboratory Value: Aspartate Aminotransferase (AST)
Description
Aspartate Aminotransferase (AST)
Time Frame
Through study completion, up to 60 Months
Title
Laboratory Value: Alanine Aminotransferase (ALT)
Description
Alanine Aminotransferase (ALT)
Time Frame
Through study completion, up to 60 Months
Title
Laboratory Value: Gamma-glutamyl Transferase (GGT)
Description
Gamma-glutamyl Transferase (GGT)
Time Frame
Through study completion, up to 60 Months
Title
Laboratory Value: Bilirubin - Total Bilirubin
Description
Bilirubin - Total Bilirubin
Time Frame
Through study completion, up to 60 Months
Title
Laboratory Value: Bilirubin - Conjugated Bilirubin
Description
Bilirubin - Conjugated Bilirubin
Time Frame
Through study completion, up to 60 Months
Title
Laboratory Value: Bilirubin - Unconjugated Bilirubin
Description
Bilirubin - Unconjugated Bilirubin
Time Frame
Through study completion, up to 60 Months

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) Participated in a PBC study with seladelpar 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: Exclusion criteria are only applicable for subjects with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption. Treatment-related adverse event (AE) leading to seladelpar discontinuation in a previous PBC study with 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 or ALT above 3 × the upper limit of normal (ULN) Total bilirubin above 2 × ULN MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN) eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula) Auto-immune hepatitis Primary sclerosing cholangitis Known history of alpha-1-antitrypsin deficiency Known history of chronic viral hepatitis For females, pregnancy or breast-feeding Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening Current use of fibrates or use of fibrates within 3 months prior to Screening Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening 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 Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics) Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis Positive for: Hepatitis B, defined as the presence of hepatitis B surface antigen Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA) Human immunodeficiency virus (HIV) antibody Active COVID-19 infection during screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barry Crittenden, MD
Phone
510-293-8800
Email
medinfo@cymabay.com
Facility Information:
Facility Name
Arkansas Diagnostic Centre
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
California Pacific Medical Center- Sutter Pacific Medical Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Covenant Metabolic Specialist LLC
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Digestive Health Specialist
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Name
Schiff Center for Liver Diseases/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Covenant Metabolic Specialist LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Chicago Institutional Review Board
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Name
MNGI Digestive Health, P.A.
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55117
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Therapy and Advanced Research (STAR), LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health Center for Liver Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center - PPDS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Galen Hepatology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt Hepatology and Liver Transplant
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Name
U.T. Southwestern Medical Center Investigation Drug Service
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
American Research Corporation at the Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Clinical Research, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryview Hospital Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Name
Richmond Community Hospital LLC., d/b/a Bon Secours Liver Institute of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
CINME (Centro de Investigaciones Metabolicas
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aries
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
DIM Clinica Privada
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
B1704ETD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de la Plata
City
La Plata
State/Province
Buenos Aries
ZIP/Postal Code
B1900AX
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University of Calgary Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centro Clinico Mediterraneo
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720506
Country
Chile
Individual Site Status
Recruiting
Facility Name
Interni a Kardiologicka Klinika-Oddeleni Gastroenterologie a Hepatologie
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Hopital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Universitatsklinik Tubingen, Medizinische Klinik, Innere Medizin I
City
Tübingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Erlangen, Medizinische Klink I, Gastroenterologie
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gastroenterologische Gemeinschaftspraxis
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44623
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gastroenterologisch - Hepatologisches Zentrum Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24146
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite Universitatsmedizin Berlin, Medizinische Poliklinik
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ifi-Medizin GmbH
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Individual Site Status
Recruiting
Facility Name
General University Hospital of Larissa Department of Medicine and Research Laboratory of Internal Medicine
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
State/Province
Ulloi
ZIP/Postal Code
1082
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center - PPDS
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Liver Disease Center, Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center PPDS
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
ASST di Monza
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara
City
Baggiovara
State/Province
Modena
ZIP/Postal Code
41126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Centre
City
Sŏngdong
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Consultorio Medico - Distrito Federal
City
Ciudad de Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
City
Metepec
ZIP/Postal Code
52140
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Radboudumc/Research Unit MDL
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Dunedin Hospital
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9016
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Gastroenterologii i Hepatologii
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Individual Site Status
Recruiting
Facility Name
ID Clinic Arkadiusz Pisula
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Federal state budget educational institution of high education "Stavropol state medical university"
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
0896
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital clinic De Barcelona
City
Barcelone
State/Province
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ankara Gazi University Faculty of Medicine Hospital
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Sehir Hastanesi, Universiteler Mahallesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty, Kazimdirik Mah
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Derriford Hospital
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Portsmouth Hospitals University NHS Trust
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
P06 3LY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospital Birmingham - Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B152TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E11FR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle Upon Tyne Hospital NHS Foundation Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE45PL
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

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