Albumin and Enoxaparin in Decompensated Cirrhosis
Research type
Research Study
Full title
A novel COMBinATorial therapy with albumin and enoxaparin in patients with decompensated cirrhosis at high-risk of poor outcome (COMBAT trial).
IRAS ID
1009190
Contact name
Pau Doñate Mecian
Contact email
Sponsor organisation
EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE
Eudract number
2023-507073-18
Clinicaltrials.gov Identifier
Research summary
An exploratory, open-label (participants and their carers are aware of which treatment protocol is being given) , multicenter, randomized (allocation to test drugs or just standard therapy equally distributed) clinical trial
The study is conducted in 9 European clinical centers: 3 in Spain, 2 in Italy and Germany, 1 in France and 1 in United Kingdom.
The clinical trial comprises 90 participants and will be conducted to determine primarily whether a combination of two drugs, human albumin (a blood product) and enoxaparin (a drug used to reduce blood clotting) , is safe and effective in patients with cirrhosis (a disease characterized by scarring of the liver which compromises its function). This trial will include participants discharged from the hospital after a hospitalization due to development of specific, cirrhosis-related complications, associated with re-admissions and poor outcomes The effects of the combination of drugs on the biology of the disease will be also evaluated.
Participants will be placed into either of two treatment groups at random, based on a computer-generated code:
- Standard of care plus the combination of the two drugs under study up to a maximum of 90 days from inclusion
- Standard of care treatment only.
Participants will be followed up to a maximum of 180 days from inclusion or up until undergoing liver transplantation.REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0197
Date of REC Opinion
23 Apr 2024
REC opinion
Further Information Favourable Opinion