Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)
Status:
Terminated
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
The study is aimed to compare the efficacy and tolerability of a combination therapy with
ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs.
ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on
ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at
risk for disease progression. It is assumed that the combination therapy will result in a
decrease of treatment failures after 3 years of treatment.