Clinical Trial: Granulocyte Colony Stimulating Factor (G-CSF) to Treat Acute-on-chronic Liver Failure
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Granulocyte Colony Stimulating Factor (G-CSF) to Treat Acute-on-chronic Liver Failure: A Multicentre Randomized Trial
Brief 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.
Detailed Summary: 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.
Sponsor: University of Leipzig
Current Primary Outcome: Transplant-free survival up to 90 days (death or transplant count as events) [ Time Frame: 90 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall survival time until the end of follow-up [ Time Frame: 360 days ]
- Transplant-free survival time until the end of follow-up [ Time Frame: 360 days ]
- Complications of ACLF (hepatorenal syndrome (HRS), variceal bleeding, ascites, hepatic encephalopathy (HE)) [ Time Frame: 90 days/360 days ]
- Infections (proven infection necessitating systemic use of antibiotics) [ Time Frame: 90 days/360 days ]
- Liver function - assessed by MELD-Score - during the course of treatment and follow-up [ Time Frame: 360 days ]
- Liver function - assessed by Child-Pugh-Score - during the course of treatment and follow-up [ Time Frame: 360 days ]
- Duration of the initial hospital stay [ Time Frame: up to 360 days ]
Original Secondary Outcome: Same as current
Information By: University of Leipzig
Dates:
Date Received: January 22, 2016
Date Started: February 2016
Date Completion: January 2019
Last Updated: September 5, 2016
Last Verified: September 2016