NASH-EX-1114
Research type
Research Study
Full title
Clinical Study of the BreathID® System to train the algorithm for the 13C-Octanoate Breath Test with or without the 13C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings of Non-Alcoholic Fatty Liver Disease (NAFLD).
IRAS ID
177377
Contact name
Quentin Anstee
Contact email
Sponsor organisation
Exalenz Bioscience Ltd.
Eudract number
2014-005411-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The Sponsor’s goal is to develop a point-of-care device for the characterization of Non-Alcoholic Fatty Liver Disease (NAFLD) compared to liver histology findings, using 13C-Octanoate Breath Test (OBT) and 13C-Methacetin Breath Test (MBT). In that sense, the sponsor propose to train a selected OBT ± MBT-based variable to reliably correlate with NAFLD histological characteristics. This will enable the use of OBT ± MBT to assess NAFLD by means of rule-in or rule-out or both.
At least 200 patients suspected of having NAFLD and meeting all inclusion/exclusion criteria will be enrolled. They will have a fresh liver biopsy (aged of maximum 6 months). They will undergo a blood test followed by a first respiratory test, the OBT, which last approximately one hour. Between 48 hours and 30 days after the OBT, the patients will undergo the second respiratory test, MBT. A safety phone call will be done 48 hours after the second respiratory test. 18 months and 36 months after the last breath test, the patients will undergo a follow-up visit (by phone or in-person) for clinical evaluation.
Data collected via the respiratory tests will be compared with the histological findings from the liver biopsy.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0159
Date of REC Opinion
30 Jun 2015
REC opinion
Further Information Favourable Opinion