Granulocyte Colony Stimulating Factor (G-CSF) to Treat Acute-on-chronic Liver Failure
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02669680 |
Recruitment Status
:
Recruiting
First Posted
: February 1, 2016
Last Update Posted
: September 7, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute-On-Chronic Liver Failure | Drug: G-CSF Other: Standard therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 292 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Granulocyte Colony Stimulating Factor (G-CSF) to Treat Acute-on-chronic Liver Failure: A Multicentre Randomized Trial |
Study Start Date : | February 2016 |
Estimated Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | January 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: G-CSF + Standard therapy
Standard care of acute-on-chronic liver failure and application of G-CSF
|
Drug: G-CSF
G-CSF subcutaneously, 5 μg/kg daily on day 0-4, then every 3rd day over 26 days (days 7, 10, 13, 16, 19, 22, 25) = 12 doses
Other Name: Filgrastim
Other: Standard therapy
|
Active Comparator: Standard therapy
Standard care of acute-on-chronic liver failure
|
Other: Standard therapy |
- Transplant-free survival up to 90 days (death or transplant count as events) [ Time Frame: 90 days ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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].
- Age ≥ 18 years, male or female
- 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:
- Prior not curatively treated or active malignancies
- Sickle cell disease
- Septic shock as defined by ACCP/SCCM consensus [Bone 1992]
- WBC-count of > 50 x 109/L
- Known HIV infection
- Known intolerance to filgrastim
- Suspected lack of compliance
- Pregnant or nursing women
- 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).
- Participation in other interventional trials

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669680
Contact: Cornelius Engelmann, MD | 0049 34197 ext 12330 | Cornelius.Engelmann@medizin.uni-leipzig.de | |
Contact: Anett Schmiedeknecht, PhD | 0049 34197 ext 16256 | anett.schmiedeknecht@zks.uni-leipzig.de |
Germany | |
University Hospital of Leipzig; | Recruiting |
Leipzig, Sachsen, Germany, 04103 | |
Contact: Cornelius Engelmann, MD | |
Klinikum St. Georg gGmbH | Recruiting |
Leipzig, Sachsen, Germany, 04129 | |
Contact: Ingolf Schiefke, Prof. MD |
Principal Investigator: | Cornelius Engelmann, MD | University Hospital of Leipzig; |
Responsible Party: | Cornelius Engelmann, MD, University of Leipzig |
ClinicalTrials.gov Identifier: | NCT02669680 History of Changes |
Other Study ID Numbers: |
GRAFT |
First Posted: | February 1, 2016 Key Record Dates |
Last Update Posted: | September 7, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Additional relevant MeSH terms:
Liver Failure End Stage Liver Disease Acute-On-Chronic Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases |
Liver Failure, Acute Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |