Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure: Amulticentre randomized Trial

Phase 1

• Conditions: Acute-on-chronic liver failure (ACLF); MedDRA version: 20.1Level: LLTClassification code 10068752Term: Acute on chronic hepatic failureSystem Organ Class: 100000004871; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-002212-32-DE
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-27
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 292

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified