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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III/IV

Latest Information Update: 29 May 2025

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At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Therapeutic Use
  • Acronyms AFFIRM
  • Sponsors Gilead Sciences

Most Recent Events

  • 28 Mar 2025 Planned number of patients changed from 192 to 318.
  • 28 Mar 2025 Planned End Date changed from 1 Jul 2029 to 1 Aug 2030.
  • 28 Mar 2025 Planned primary completion date changed from 1 Jul 2029 to 1 Aug 2030.

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