Clinical Trial Investigating Seladelpar in Patients with Primary Biliary Cholangitis

Clinical Trial Title

Phase III clinical trial drug study for patients with Primary Biliary Cholangitis, the RESPONSE study

National Clinical Trial Number:

NCT04620733

Contact Information

Clinical Trial Protocol Description:

Phase III clinical trial investigating the use of seladelpar compared with placebo in patients with Primary Biliary Cholangitis and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA). Subjects will be randomized in 2:1 ratio (seladelpar: placebo).

Clinical Trial Eligibility Criteria:

In order to participate in this study, you must have confirmed PBC as defined by having any 2 of the following 3 diagnostic criteria:

  1. History of ALP above 1.0× the upper limit of normal (ULN) for at least 6 months.
  2. Positive antimitochondrial antibody (AMA) titer (>1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay [ELISA]) or positive PBC-specific antinuclear antibodies (ANAs).
  3. Documented liver biopsy results consistent with PBC.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Nikunj Shah

Contact Information

Diana Goldman

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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