Biliary Cirrhosis, Primary Clinical Trial
Official title:
An Exploratory, Phase IIa Study to Demonstrate the Safety and Efficacy of A4250 in Patients With Primary Biliary Cirrhosis and Cholestatic Pruritus
This study will evaluate the safety, tolerability and influence on itching, bile acids and liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250
A4250PBCpruritus (EudraCT 2014-004070-42) is an open-label exploratory study.
The primary objective of this study is to assess the safety and tolerability of A4250, 1.5 -
3 mg orally during a four-week treatment period, in patients with PBC and cholestatic
pruritus, as determined by the occurrence of treatment-emergent serious adverse events
(SAEs).
Other safety objectives of this study include assessment of the safety and tolerability of
A4250 during a four-week treatment period, as determined by the occurrence of
treatment-emergent adverse events (AEs) and changes in other safety parameters including
liver and kidney function tests and vital signs.
Exploratory efficacy objectives of this study are to demonstrate the efficacy of A4250
orally on pruritus variables and on QoL and lysophosphatidic acid formation as well as
evaluation of changes in pharmacodynamic parameters of bile acid metabolism such as serum
and fecal bile acids, C4 and fibroblast growth factor 19 (FGF19) assessments and assessment
of surrogate markers of cholestatic liver disease such as alkaline phosphatase,
transaminases and bilirubin.
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