O10 Granulocyte-Colony Stimulating Factor (G-CSF) to treat acute-on-chronic liver failure; results of the first multicenter randomized trial (GRAFT study)
نویسندگان
چکیده
Background The acute-on-chronic liver failure (ACLF) is a severe complication of cirrhosis characterised by immune dysfunction and high mortality. Granulocyte-colony stimulating factor (G-CSF) mobilises immunomodulatory stem cells has been proposed as therapy for ACLF. We therefore conducted the first multicentre randomised trial. Methods In this prospective, controlled, open-label 2-armed study 176 patients with ACLF according to EASL-CLIF criteria without malignancies or septic shock were in 18 trial centres between 02/2016 01/2019 1:1 ratio receive either standard medical (SMT) SMT plus G-CSF (12 injections 5µg/kg 5days daily, then every 3 days). primary efficacy endpoint was 90-day transplant free survival (TFS90). Results 34.1% group compared 37.5% corresponding hazard (HR) 1.05 (95%CI 0.711; 1.551) (p=0.805). G.CSF had no effect on 360-day [HR 0.998 [95%CI 0.697; 1.430 (p=0.992)] overall 1.058 0.727; 1.548 (p=0.768)]. There improvement CLIF-C OF score (p=0.757), MELD (p=0.884) rate bacterial infections (p=0.251) therapy. subgroups [p=0.883], alcohol related [p=0.875], defined APASL [p=0.405] also didn’t improve survival. 61 serious adverse events (SAE) reported G-CSF+SMT 57 SAEs including seven drug-related reactions under prematurely terminated due futility. Conclusion This interim analysis reveals that therapeutic ACLF, which obvious contrast results from smaller clinical trials published previously. As consequence, futility after conditional power calculation.
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ژورنال
عنوان ژورنال: Oral
سال: 2021
ISSN: ['2673-6373']
DOI: https://doi.org/10.1136/gutjnl-2021-basl.10