Grifols ALADDIN study
Research type
Research Study
Full title
Pathogenesis of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) in Decompensated Cirrhotic Subjects with Systemic Inflammation and ACLF
IRAS ID
256491
Contact name
William Bernal
Contact email
Sponsor organisation
Instituto Grifols S.A.
Clinicaltrials.gov Identifier
2017-002677-19, EUDRACT Number
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This is a translational study which is aimed to understand and explore the development of different stages of liver disease and to investigate the disease process through the blood tests which are being performed for this study. This study will analyse results from blood samples obtained from patients included in the APACHE study( Previously submitted-IRAS 252651-18/NE/0311) as well as non-ACLF patients, to help with getting a better understanding of the disease process and to see if there could be a better way to treat patients with liver disease.
A maximum of 250 subjects will be enrolled in this study across 3 study groups.
Group 1 will include a maximum of 75 subjects with Acute on Chronic Liver Failure (ACLF) enrolled in the APACHE study who are receiving the SMT (standard medical treatment) + PE-A 5% treatment (Plasma Exchange plus 5% Albumin).
Group 2 will be comprised of a maximum of 75 subjects with ACLF enrolled in the APACHE study who are receiving standard medical treatment from the study doctor and not receiving the PE-A 5%.
Group 3 will include a maximum of 100 control subjects with cirrhosis without ACLF.
Approximately 14 study centers in Europe that are also participating in the APACHE study are planned to participate in the ALADDIN study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0131
Date of REC Opinion
3 Jul 2019
REC opinion
Further Information Favourable Opinion