Clinical Trials Logo

Clinical Trial Summary

Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with acute on chronic liver failure (ACLF) who meet inclusion/exclusion criteria.The objective of GRAFT-trial is to evaluate efficacy and safety of subcutaneously administered granulocyte colony-stimulating factor (G-CSF) in patients with ACLF. All patients will receive standard medical care for ACLF according to the guidelines. Patients in the experimental arm additional receive subcutaneous injections of G-CSF.


Clinical Trial Description

The acute on chronic liver failure (ACLF) is characterised by a severe deterioration of liver function due to a precipitating event on top of an underlying chronic liver disease. As therapeutic options are limited the mortality rate lies between 40 and 80% at 3 months. The granulocyte colony-stimulating factor (G-CSF) mobilized stem- as well as immune cells and improved liver function in preclinical trials. G-CSF treatment reduced the rate of infectious complications and significantly improved patients´ survival in acute on chronic liver failure, shown recently in small randomised studies. Thus, G-CSF is a promising treatment option that needs to be evaluated in a multi-centre controlled trial. The GRAFT trial will randomise patients with ACLF between standard of care with and without G-CSF. All participants will be followed for 12 months in order to evaluate safety and efficacy of G-CSF. If successful, the GRAFT trial has the potential to change clinical practice in acute on chronic liver failure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02669680
Study type Interventional
Source University of Leipzig
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date March 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05985863 - Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT04822922 - Safety of UC-MSC Transfusion for ACLF Patients Phase 2
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Completed NCT04983108 - Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure
Withdrawn NCT05940610 - The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05019352 - Cytokine Adsorption in Acute-on-chronic Liver Failure N/A
Recruiting NCT05421351 - Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Completed NCT02321371 - Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy. N/A
Not yet recruiting NCT06069037 - SALT for Treatment of Patients With Early ACLF N/A
Completed NCT02965560 - Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Recruiting NCT03713489 - Platelet Transfusion in HBV-related acute-on Chronic Liver Failure N/A
Withdrawn NCT03629015 - Safety Study of Stemchymal® in Acute Liver Failure Phase 1
Recruiting NCT04621812 - Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Suspended NCT03737448 - TRimetazidine for acUte on Chronic Liver Failure STudy Phase 1
Recruiting NCT06128421 - Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk N/A
Recruiting NCT05700708 - Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Completed NCT04238416 - Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF Phase 1
Completed NCT03456518 - Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease