Documentation of hepatic encephalopathy in clinical practice
Research type
Research Study
Full title
An observational study to assess documentation of hepatic encephalopathy in clinical practice
IRAS ID
165904
Contact name
Bruce Scharschmidt
Contact email
Sponsor organisation
Hyperion Therapeutics
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
This is a non-interventional, multi-center study, to be conducted in up to 20 countries and up to 130 sites, to collect data on how clinicians document signs and symptoms of overt HE in clinical practice.
It is designed to permit all qualified and interested clinician providers to participate as investigators, and all interested patients to participate.
Patients will be followed per usual medical practice and evaluated for overt HE episodes in the course of their care. There will be no study specific visits, labs or tests administered as a requirement of participation.
Patients enrolled in this study will be required to provide access to their health information, including prospective data collection, for up to 12 months and the review of their medical history for 30 days prior to consent.
The study will last up to 12 months for each patient, i.e. consenting
patients who experienced an episode of overt HE within the last 30 days will be enrolled and their HE episodes recorded for up to 12 months.REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/2159
Date of REC Opinion
12 Dec 2014
REC opinion
Favourable Opinion