Primary Biliary Cholangitis: Bezafibrate Administered in Combination with Obeticholic Acid

Summary

This study focuses on individuals who have primary biliary cholangitis (PBC). The purpose of the study is to determine whether obeticholic acid (OCA) in combination with an investigational drug, bezafibrate (BZF), has an effect on the patient’s PBC. OCA is a man-made version of a natural compound, bile acid, which is made in the liver. Bile acids are used by the body to help with digestion and have additional effects on liver function. OCA has been shown to improve markers of liver function when used as a single drug in subjects with PBC. Bezafibrate has been shown to decrease triglycerides and LDL cholesterol (“bad cholesterol”) and increase HDL (“good”) cholesterol. It has also been shown in some studies to have a positive effect on bile acids, liver function laboratory values, and pruritus (itching) in PBC. Researchers will assess the effects of the combination of OCA and two different doses of BZF on alkaline phosphatase (ALP; a marker of liver function) in comparison to BZF alone at two different doses. Abnormal levels of ALP in the blood could indicate issues relating to the liver, gallbladder, or bones.


Inclusion Criteria

  • A definite or probable diagnosis of PBC
  • Qualifying ALP and/or bilirubin liver biochemistry values
  • Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis

Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

II

IRB Number

STUDY00002023

ClinicalTrials.gov ID

NCT05239468

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

II

IRB Number

747-214

ClinicalTrials.gov ID

NCT05239468

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?