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Budesonide plus ursodeoxycholic acid versus placebo plus ursodeoxycholic acid in primary biliary cholangitis
2007-004040-70Phase 3Completed
- Sponsor
- Dr. Falk Pharma GmbH
- Start
- Mar 2008
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in primary biliary cholangitis (PBC) comparing Budesonide + ursodeoxycholic acid with Placebo + ursodeoxycholic acid (2 arms). Primary endpoint: Histologic improvement without fibrosis progression. Started Mar 2008; status: completed.
02
Drugs
budesonideursodeoxycholic acid
03
Conditions
primary biliary cholangitis (PBC)
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