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Primär biliäre Zirrhose (PBC)

BUC-56/PBC

Title: Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis.
Sponsor: Falk Pharma
Brief summary: To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight) plus budesonide (9 mg/d) vs. UDCA and placebo in the treatment of PBC who are at risk for disease progression (aP ≥ 3 ULN or ALT ≥ 2 ULN or bilirubin ≥ 1 mg/dl during UDCA treatment).
Study phase: III
Principal investigator: PD Dr. Rust
Status: Einschluß möglich. Kontakt: PD Dr. Rust, Dr. Pusl, Dr. Denk


URT-15/PBC

Title: Double-blind, double-dummy, randomised, crossover, multicenter phase IV clinical study comparing the effect of Ursofalk 500 mg tablets od versus Ursofalk 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis (PBC).
Sponsor: Falk Pharma
Brief summary: The primary objective of this study is to compare the efficacy of Ursofalk 500 mg tablets (14±2 mg(kg body weight) vs. Ursofalk 250 mg capsules (14±2 mg(kg body weight) in the treatment of PBC (stage I and II). Secondary objectives will be to assess the safety and tolerability in the form of adverse events and laboratory parameters and patients quality of life.
Study phase: IV
Principal investigator: PD Dr. Rust
Status: Einschluß möglich. Kontakt: PD Dr. Rust, Dr. Pusl, Dr. Denk


INT-747-201

Title: A multi-center, randomised, placebo-controlled study of INT-474 (6-ECDCA) monotherapy in patients with primary biliary cirrhosis (PBC).

Sponsor: Intercept Pharmaceuticals
Brief summary: This is a multi-dose, parallel-group study of INT-747 in patients with PBC. Two dose levels (10 and 50 mg) of INT-747 and placebo will be administered orally (PO), daily (QD), for 12 weeks. Screening AP level between 1.5 and 10 × ULN are required. The primary objective is the reduction of aP-levels, secondary endpoints are safety and disease-specific symptoms as assessed by PBC-40 and SF-36.
Study phase: II
Principal investigator: PD Dr. Rust
Status: Einschluß möglich. Kontakt: PD Dr. Rust, Dr. Pusl, Dr. Denk


INT-747-202

Title: A multi-center, randomised, placebo-controlled study of INT-474 (6-ECDCA) in combination with ursodeoxycholic acid in patients with primary biliary cirrhosis (PBC).
Sponsor: Intercept Pharmaceuticals
Brief summary: This is a multi-dose, parallel-group study of INT-747 in patients with PBC. Three dose levels (10, 25 and 50 mg) of INT-747 and placebo will be ad-ministered orally (PO), daily (QD), in combination with UDCA for 12 weeks. The primary objective is the reduction of aP-levels, secondary endpoints are safety and disease-specific symptoms as assessed by PBC-40 and SF-36.
Study phase: II
Principal investigator: PD Dr. Rust
Status: Ongoing, aber Rekrutierung abgeschlossen.