OVERVIEW
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
PROTOCOL SUMMARY
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
View moreParticipation requirements
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Primary Biliary Cirrhosis
Gender
N/A
Date
December 2017 - November 2028
Study Type
Interventional
Study Phase
Phase 3
Product
Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
Eligibility information
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 individuals 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 individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption.
- 1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
- 2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
- 3. AST or ALT above 3 × the upper limit of normal (ULN)
- 4. Total bilirubin above 2 × ULN
- 5. MELD score ≥ 12. For individuals 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 (eg 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 individual or compromise the quality of the clinical study, as judged by the Investigator
- 20. Immunosuppressant therapies (eg, 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (109)
Arkansas Diagnostic Center
Little Rock, Arkansas, United States, 72205
Stanford University School of Medicine
Palo Alto, California, United States, 94305
California Liver Research Institute
Pasadena, California, United States, 91105
University of California Davis Medical Center
Sacramento, California, United States, 95817
California Pacific Medical Center
San Francisco, California, United States, 94115
University of Colorado - Denver - PPDS
Aurora, Colorado, United States, 80045
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Covenant Research Fort Myers
Fort Myers, Florida, United States, 33606
Florida Digestive Health Specialist
Lakewood Rch, Florida, United States, 34211
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Digestive Healthcare of Georgia PC
Atlanta, Georgia, United States, 30309
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
East Jefferson General Hospital
New Orleans, Louisiana, United States, 70112
Mercy Medical Center (Baltimore)
Baltimore, Maryland, United States, 21202
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center - 330 Brookline Ave
Boston, Massachusetts, United States, 02215
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States, 55413
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States, 39157
Weill Cornell Medical College
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
University of Rochester Medical Center - PPDS
Rochester, New York, United States, 14642
Duke University Medical Center
Durham, North Carolina, United States, 27710
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States, 18017
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Gastro One-8110 Walnut Run Rd
Cordova, Tennessee, United States, 38018
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 39090
Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
The Texas Liver Institute - 607 Camden St
San Antonio, Texas, United States, 78215 1619
Pinnacle Clinical Research, PLLC
San Antonio, Texas, United States, 78229
Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States, 23602
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States, 23226
Liver Institute Northwest, PLLC
Seattle, Washington, United States, 98195
CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278
Balvanera, Argentina, C1056ABJ
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Hospices Civils de Lyon - Hôpital de La Croix Rousse
Lyon, France, 69004
Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134
Kiel, Germany, 24146
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Israel, 6423906
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, Italy, 41126
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2
Palermo, Italy, 90127
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
Metepec, Mexico, 52120
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
Katowice, Poland, 40-752
SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov
Saint Petersburg, Russia, 197110
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea, 14584
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, Spain, 28755
Ege Universitesi Tip Fakultesi Hastanesi
Bornova, Turkey (Türkiye), 35100
Marmara University Pendik Training and Research Hospital
Maltepe, Turkey (Türkiye), 34840
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Topkapı, Turkey (Türkiye), 34093
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London, United Kingdom, E1 1BB
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE4 6BE
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