TARA-001-502: Protara IFALD Prospective Prevalence Study
Research type
Research Study
Full title
A ProspecTive Prevalence Study in Adolescent and Adult Patients Dependent on Parenteral Nutrition to Assess tHe Incidence of Intestinal FailuRe-AssocIated LiVer DiseasE
IRAS ID
300777
Contact name
Farooq Rahman
Contact email
Sponsor organisation
Protara Therapeutics
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 28 days
Research summary
Research Summary:
This study does not involve the administration of any drugs (investigational or approved). This study is to collect information about patients that are receiving parenteral nutrition, the intravenous administration of nutrition. The patient’s doctor decides what parenteral nutrition is required and appropriate for each patient. The patient will be recruited by the research site staff for participation in the clinical study based on their medical and parenteral nutrition history. The patient will sign an informed consent to participate in the study and allow the research staff to perform the necessary assessments and blood draws at Visit 1. The patient will provide three blood samples at Visit 1 for choline, serum ALP liver isoenzyme levels and a liver panel to determine if the patient is choline deficient or has liver dysfunction as determined by elevated serum ALP liver isoenzyme levels and liver panel results. If a patient is determined to having both choline deficiency and elevated serum ALP liver isoenzyme levels, the research staff will request/schedule the patient to return for a second clinic visit, Visit 2, for imaging of the patient’s liver via Magnetic Resonance Imaging (MRI).Lay summary of study results:
Lay summary is not currently availableREC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0824
Date of REC Opinion
21 Jan 2022
REC opinion
Further Information Favourable Opinion