Primary Biliary Cholangitis: Setanaxib in PBC and Elevated Liver Stiffness

Summary

The purpose of this study is to determine the safety and effectiveness of an experimental drug called setanaxib for the treatment of primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis). PBC is a liver disease caused by an attack of the individual’s own immune system on specific structures of the liver and bile duct. Previous clinical results with setanaxib in PBC indicated that setanaxib achieved reductions in markers (indicators) of cholestatic injury, improved markers of liver fibrosis, and improved quality of life. Researchers hope to confirm these findings in the current study. Participants will be randomly assigned to 1 of 3 groups. One group will receive setanaxib 1200 mg/day; the second group will receive setanaxib 1600 mg/day; and the third group will receive placebo (inactive substance).


Inclusion Criteria

  • Male or female participant aged ≥18 years, inclusive at the time of informed consent.
  • Willing and able to give written informed consent and to comply with the requirements of the study.
  • Definite or probable primary biliary cholangitis (PBC) diagnosis as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis and Elevated Liver Stiffness

Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

II/III

IRB Number

STUDY00002180

ClinicalTrials.gov ID

NCT05014672

Key Eligibility
ClinicalTrials.gov

Contact
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/III

IRB Number

GSN000350

ClinicalTrials.gov ID

NCT05014672

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?