NCT00746486View on ClinicalTrials.gov

Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)

PHASE3TerminatedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

October 31, 2019

Study Completion Date

October 31, 2019

Conditions
Primary Biliary Cirrhosis
Interventions
DRUG

budesonide

One budesonide 3 mg capsule TD or one budesonide 3 mg capsule BD and 12-16 mg ursodeoxycholic acid/kg BW/d for 3 years

DRUG

budesonide placebo

One placebo capsule TD or One placebo capsule BD and 12-16 mg ursodeoxycholic acid/kg BW/d for 3 years

Trial Locations (2)

53105

Universitätsklinikum Bonn, Bonn

75571

Hôpital Saint-Antoine, Paris

Sponsors
All Listed Sponsors
lead

Dr. Falk Pharma GmbH

INDUSTRY