Extension study of LUM001 in patients with PBC (CASCADE Study)
Research type
Research Study
Full title
An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Tolerability of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Primary Biliary Cirrhosis
IRAS ID
168030
Contact name
Gideon Hirschfield
Contact email
Sponsor organisation
Lumena Pharmaceuticals UK
Eudract number
2014-003433-26
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
This is an open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001. LUM001 can stop bile acids from being absorbed from the gut into the body. It can lower the amount of bile acids in the blood and may reduce itching in people with primary biliary cirrhosis. This is an extension study to a current study, LUM001-201. For an individual subject, study participation will consist of a screening period of up to 4 weeks, followed by the treatment period which includes a 3-week dose escalation period. Subjects will continue dosing for up to 2 years, or until LUM001 is either commercially available or the Sponsor's decision to terminate the study.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0011
Date of REC Opinion
15 Jan 2015
REC opinion
Favourable Opinion