Granulocyte-Colony Stimulating Factor (G-CSF) as Optimizing Therapy for Pediatric Liver Transplantation

July 26, 2022 updated by: Tri Hening Rahayatri, Fakultas Kedokteran Universitas Indonesia

The Role of Granulocyte-Colony Stimulating Factor (G-CSF) for Improving PELD Score and Nutritional Status in Pediatric Liver Cirrhosis Prior to Liver Transplantation Through Immunomodulation of Neutrophil, CD34+ Cell, TNF-α and IL-10

This study compares the effect of human recombinant Granulocyte-Colony Stimulating Factor (G-CSF) in pediatric patients with liver cirrhosis with a control group. The study aims to observe improvement of (Pediatric End-stage Liver Disease) PELD score and nutritional status prior to liver transplantation procedure. In addition to the intervention, standard treatments for liver cirrhosis are also given for both groups. G-CSF is administered for 12 times.

Condition of disease:

Pediatric patient aged 3 months to 12 years old Liver cirrhosis Undernourished / Severe malnutrition PELD score 10-25

Intervention:

Drug: Recombinant Human G-CSF

Phase:

Phase 3

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open-label randomized control trial conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, aimed to determine the effect of G-CSF to improve PELD score and nutritional status of pediatric patients with liver cirrhosis prior to liver transplantation. A total of 52 pediatric patients with liver cirrhosis, malnutrition and PELD score between 10-25 will be collected and divided into intervention group and control group. The intervention group will be given a subcutaneous injection of G-CSF 5μg/kg/day for 5 days consecutively, followed by a single dose every 3 days up to 12 times throughout the trial. Additionally, both the intervention and control group receive standard liver cirrhosis treatment. Randomization is done using block randomization.

The patients will be clinically monitored and evaluated for anthropometric changes (body weight, mid-arm circumference, mid-arm muscle circumference, and triceps skinfold thickness), complete blood count, absolute neutrophil count, liver function tests, cytokines (IL-10, TNF-α), Procalcitonin, hepatocyte growth factor (HGF), CD34+ cell count and PELD score (albumin, bilirubin, prothrombin and international normalized ratio values).

Data analysis will be performed using IBM SPSS Statistics version 20.0.0.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Java
      • Jakarta, Java, Indonesia, 16424
        • Fakultas Kedokteran Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 3 months to 12 years old
  • Conscious state
  • Without the presence of fever (temperature: <37,5°C)
  • Decompensated liver cirrhosis
  • Liver cirrhosis due to various etiology
  • Undernourished or severe malnutrition
  • PELD score between 10-25

Exclusion Criteria:

  • Malignancy (liver origin or other types)
  • History of undergoing any organ transplantation procedure
  • Acute liver failure
  • Failure of any organ other than the liver
  • Encephalopathy
  • Severe infection such as bacterial peritonitis and pneumonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Subcutaneous injection of G-CSF with dose of 5μg/kg/day for 5 days consecutively, in addition to a single dose every 3 days up to 12 times, as well as liver cirrhosis standard regimen
Drug: G-CSF (Filgrastim)
Contains 0,59 mg of acetate, 0,04 mg of polysorbate 80, 0,035 mg of sodium, 50 mg of sorbitol
Other Names:
  • Neupogen
No Intervention: Control Group
Liver cirrhosis standard treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PELD Score
Time Frame: 90 days
The scoring determines the individual's need for liver transplant. Calculation is based on an equation that incorporates the values of bilirubin serum, international normalized ratio, albumin and body growth measurement. Score ranges between 6 (low illness level) to 40 (severely ill).
90 days
Anthropometric Changes
Time Frame: 90 days
Measurement of mid-arm circumference (MAC) will be obtained in centimeters and be plotted on the curve to observe changes in nutritional status
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pro-inflammatory Marker
Time Frame: 30 days
Tumor necrosis factor alpha (TNF-α) cytokine level in the blood will be the parameter for pro-inflammatory marker
30 days
Anti-inflammatory Marker
Time Frame: 30 days
Interleukin-10 (IL-10) cytokine level in the blood will be the parameter for anti-inflammatory marker
30 days
Liver Regeneration Marker
Time Frame: 30 days
hepatocyte growth factor (HGF) serum level will be the biochemical parameter for liver regeneration
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakultas Kedokteran Universitas Indonesia

Collaborators

Dr Cipto Mangunkusumo General Hospital

Investigators

  • Study Chair: Tri Hening Rahayatri, MD, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital
  • Study Director: Akmal Taher, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

September 22, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FakultasKUI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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