NCA vs. placebo in PBC

• Research type

  Research Study

• Full title

  Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid

• IRAS ID

  1004635

• Contact name

  Markus Pröls, Dr.

• Contact email

  markus.proels@drfalkpharma.de

• Sponsor organisation

  Dr. Falk Pharma GmbH

• Eudract number

  2021-001431-56

• Research summary

  Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  22/EM/0084

• Date of REC Opinion

  12 May 2022

• REC opinion

  Further Information Favourable Opinion