AFFIRM

• Research type

  Research Study

• Full title

  AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

• IRAS ID

  1010591

• Contact name

  Michael Peters

• Contact email

  michael.peters2@gilead.com

• Sponsor organisation

  Gilead Sciences Inc

• Clinicaltrials.gov Identifier

  NCT06051617

• Research summary

  This is a multicenter evaluation of seladelpar, administered as a once daily oral capsule,in a randomized, double-blind, placebo-controlled, parallelgroup study in subjects with PBC. This fixed-duration study (156 weeks) will randomize approximately 192 subjects across approximately 150 sites worldwide. The population to be studied is patients with PBC and compensated cirrhosis restricted to Child-Pugh (CP)-A or CP-B.
  Approximately 192 subjects will be randomized (128 on seladelpar and 64 on placebo).

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  25/NE/0037

• Date of REC Opinion

  15 May 2025

• REC opinion

  Further Information Favourable Opinion