Granulocyte Colony Stimulating Factor (G-CSF) to Treat Acute-on-chronic Liver Failure

Launched by UNIVERSITY OF LEIPZIG · Jan 29, 2016

Keywords

ClinConnect 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. ...

Gender

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Eligibility criteria

• Inclusion Criteria:
• 1. Acute-on-chronic liver failure (ACLF) according to the consensus criteria recently defined by the CANONIC study group \[Moreau 2013\]. Patients with acute decompensation of cirrhosis \[defined as acute development of one or more of the following: ascites (onset and/or worsening), hepatic encephalopathy (onset and/or worsening), gastrointestinal haemorrhage, bacterial infection\] are classified as ACLF if one of the following applies:
• • single kidney failure (serum creatinine level ≥ 2 mg/dl) or
• • single failure of one of the following organ systems: liver, coagulation, circulation, or respiration, together with a serum creatinine level ranging from 1.5 to \< 2.0 mg/dl and/or mild to moderate hepatic encephalopathy or
• • single cerebral failure together with serum creatinine level ranging from 1.5 to \< 2.0 mg/dl or
• • two or more organ failures. Organ failures are defined according to the CLIF-C OFs \[Jalan 2014\].
• • 2. Age ≥ 18 years, male or female
• • 3. Written informed consent from patient, legal or authorized representative or a confirmation of justification of trial participation by an independent medical consultant PLEASE NOTE: In case of confirmation by the independent medical consultant a deferred informed consent from patient, legal or authorized representative has to be given
• Exclusion Criteria:
• • 1. Prior not curatively treated or active malignancies
• • 2. Sickle cell disease
• • 3. septic shock, defined by the following symptom complex: bacteraemia AND SIRS AND shock
• • 4. WBC-count of \> 50 x 109/L
• • 5. Known HIV infection
• • 6. Known intolerance to filgrastim
• • 7. Suspected lack of compliance
• • 8. Pregnant or nursing women
• • 9. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects from the trial medication on contraception).
• • 10. Participation in other interventional trials