Grifols PRECIOSA Study
Research type
Research Study
Full title
IG1601: Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites\n\nIND 17549 - EudraCT-Number: 2016-001789-28
IRAS ID
239860
Contact name
Rajiv Jalan
Contact email
Sponsor organisation
Instituto Grifols S.A
Eudract number
2016-001789-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This study is designed to evaluate the effects of Albutein 20% infusion on long-term survival in liver cirrhosis compared to the Standard Medical Treatment (SMT).\nIn this study, Albutein 20% is given by intravenous infusion for a maximum treatment period of 12 months. The purpose of this study is to determine if Albutein 20% infusion is safe and has a positive effect on disease progression.\nAlbutein 20% infusion is considered experimental treatment, meaning that it is currently being tested and has not yet been approved in your country to be used for liver cirrhosis treatment.\n\nIn this study, we are planning to confirm the proposed treatment by assessing its safety and effectiveness in improving liver cirrhosis symptoms and prognosis. Approximately 410 subjects will participate in the study at multiple study centres globally. In this study, 205 subjects will receive Standard Medical Treatment (SMT) and 205 will receive SMT+ Albutein 20%. The total maximum time of active participation in the Research Study is expected to be approximately 12 months from the first study visit after screening to the last follow-up visit.\n\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0114
Date of REC Opinion
21 Jun 2018
REC opinion
Further Information Favourable Opinion