Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Primary Biliary Cirrhosis (PBC)

In brief

The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).

Key facts

Study ID

NCT02609048

Run by

Gilead Sciences

People needed

41

Starts

2015-11-04

Expected to finish

2016-07-01

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 upper limit of normal (ULN) for at least six months
• Positive Anti-Mitochondrial Antibodies (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
• AP ≥ 1.67 × ULN
• For females of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose. For male subjects, use of appropriate contraception (e.g., condoms), so their female partners of reproductive potential do not become pregnant during the study and for at least two weeks after the last dose

You may not qualify if…

• 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 on active treatment)
• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 × ULN
• Total bilirubin > 2 × ULN
• Auto-immune hepatitis
• Primary sclerosing cholangitis
• Known history of alpha-1-Antitrypsin deficiency
• Known history of chronic viral hepatitis
• Creatine kinase above ULN
• Serum creatinine above ULN
• For females, pregnancy or breast-feeding
• Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening
• Current use of fibrates, including fenofibrates, or simvastatin
• Use of an experimental treatment for PBC
• Use of experimental or unapproved immunosuppressant
• 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

Where it is running

• Mayo Clinic of Arizona — Phoenix, Arizona, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami, Center for Liver Diseases — Miami, Florida, United States
• Norman Gitlin, MD — Atlanta, Georgia, United States
• Digestive Helathcare of Georgia — Atlanta, Georgia, United States
• Indiana University Hospital - Clinical Research Center — Indianapolis, Indiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Gastroenterology Associates of Western Michigan, PLC, d.b.a. West Michigan Clinical Research — Wyoming, Michigan, United States
• Kansas City Gastroenterology and Hepatology — Kansas City, Missouri, United States
• St. Louis University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center / The Nebraska Medical Center — Omaha, Nebraska, United States
• North Shore-Long Island Jewish Health System / Division of Gastroenterology — Manhasset, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center — New York, New York, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• CHI St. Luke's Health Baylor College of Medicine Medical Center - Advanced Liver Therapies — Houston, Texas, United States
• Pinnacle Clinical Research — Live Oak, Texas, United States
• American Research Corporation at Texas Liver Institute — San Antonio, Texas, United States
• Bon Secours St. Mary's Hospital of Richmond — Newport News, Virginia, United States
• Digestive and Liver Disease Specialists — Norfolk, Virginia, United States
• University of Calgary Liver Unit (Heritage Medical Research Clinic) — Calgary, Alberta, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Charite Universitatsmedizin Berlin - Campus Mitte — Berlin, Germany
• Leber- und Studienzentrum am Checkpoint — Berlin, Germany

Full record on ClinicalTrials.gov

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