ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Completed · Phase 3 · Has a placebo group

Conditions studied: Primary Biliary Cholangitis

In brief

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.

Key facts

Study ID

NCT03602560

Run by

Gilead Sciences

People needed

265

Starts

2018-10-01

Expected to finish

2020-02-16

Last updated by the study team

2022-08-02

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 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona - PPDS — Phoenix, Arizona, United States
• The Institute for Liver Health-Tucson — Tucson, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Stanford University School of Medicine — Redwood City, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Univeristy of Colorado Denver and Hospital — Aurora, Colorado, United States
• Yale School of Medicine Digestive Diseases, Internal Medicine — New Haven, Connecticut, United States
• Excel Medical Clinical Trials, LLC — Boca Raton, Florida, United States
• Florida Reserach Institute — Lakewood Rch, Florida, United States
• Schiff Center for Liver Diseases University of Miami — Miami, Florida, United States
• Tampa General Medical Group — Tampa, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Novi, Michigan, United States
• Minnesota Gastroenterlogy, P.A. — Maplewood, Minnesota, United States
• University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota, United States
• Southern Therapy and Advance Research (STAR) LLC — Jackson, Mississippi, United States
• Digestive Health Specialists PA — Tupelo, Mississippi, United States
• Institute for Liver Health — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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