Identification Module
The Identification Module contains basic identifying information about the clinical trial, including the NCT ID, brief title, official title, acronym, organization study ID information, and organization details. This module provides essential identifiers for the trial.
Identification Module path is as follows:
Study -> Protocol Section -> Identification Module
Identification Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT06383403
Brief Title:
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
Official Title:
A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
Acronym:
ELSPIRE
Study:
NCT06383403
Protocol Section:
NCT06383403