PROSPER - Hepatic Encephalopathy Observational Study ZZ2014GL03
Research type
Research Study
Full title
PROSPER: Prospective Real World Outcomes Study of Hepatic Encephalopathy Patients’ Experience on Rifaximin-α (TARGAXAN®/XIFAXAN®)550 mg
IRAS ID
182876
Contact name
Mark Hudson
Contact email
Sponsor organisation
Norgine Ltd
Duration of Study in the UK
2 years, 11 months, 25 days
Research summary
This is a global questionnaire study in patients with Hepatic Encephalopath (HE). HE is the occurrence of confusion and/or unconsciousness as a result of chronic liver disease.
This is an observational study, which means patients do not have to undergo additional medical procedures to those of their usual care. If a patient agrees to take part in this study they will be asked, along with their caregiver (if they have one and they wish to also participate) to complete questionnaires in relation to their current well-being for up to 24 months.
The purpose of this study is to see how effective TARGAXAN® is compared to other treatments for HE. TARGAXAN® is an antibiotic that works in the gut and is indicated to reduce the risk of HE recurrence in patients 18 years of age and older. Approximately 550 patients will take part in this study from about 50 clinics in Europe and Australasia.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0204
Date of REC Opinion
3 Aug 2015
REC opinion
Further Information Favourable Opinion