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| Name | Class |
|---|---|
| Dr Cipto Mangunkusumo General Hospital | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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 |
|
| Control Group | No Intervention | Liver cirrhosis standard treatment only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF (Filgrastim) | Drug | Contains 0,59 mg of acetate, 0,04 mg of polysorbate 80, 0,035 mg of sodium, 50 mg of sorbitol |
|
| Measure | Description | Time Frame |
|---|---|---|
| PELD Score | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-inflammatory Marker | Tumor necrosis factor alpha (TNF-α) cytokine level in the blood will be the parameter for pro-inflammatory marker | 30 days |
| Anti-inflammatory Marker | Interleukin-10 (IL-10) cytokine level in the blood will be the parameter for anti-inflammatory marker |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tri Hening Rahayatri, MD | Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital | Study Chair |
| Akmal Taher | Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultas Kedokteran Universitas Indonesia | Jakarta | Java | 16424 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27621310 | Background | Fioredda F, Lanza T, Gallicola F, Riccardi F, Lanciotti M, Mastrodicasa E, Signa S, Zanardi S, Calvillo M, Dufour C. Long-term use of pegfilgrastim in children with severe congenital neutropenia: clinical and pharmacokinetic data. Blood. 2016 Oct 27;128(17):2178-2181. doi: 10.1182/blood-2016-07-727891. Epub 2016 Sep 12. No abstract available. | |
| 28939926 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 14, 2023 | Oct 9, 2023 | 6 | ||
| Oct 10, 2023 |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| 30 days |
| Liver Regeneration Marker | hepatocyte growth factor (HGF) serum level will be the biochemical parameter for liver regeneration | 30 days |
| Dale DC, Crawford J, Klippel Z, Reiner M, Osslund T, Fan E, Morrow PK, Allcott K, Lyman GH. A systematic literature review of the efficacy, effectiveness, and safety of filgrastim. Support Care Cancer. 2018 Jan;26(1):7-20. doi: 10.1007/s00520-017-3854-x. Epub 2017 Sep 22. |
| 27350939 | Background | Yang Q, Yang Y, Shi Y, Lv F, He J, Chen Z. Effects of Granulocyte Colony-Stimulating Factor on Patients with Liver Failure: a Meta-Analysis. J Clin Transl Hepatol. 2016 Jun 28;4(2):90-6. doi: 10.14218/JCTH.2016.00012. Epub 2016 Jun 15. |
| 22119930 | Background | Garg V, Garg H, Khan A, Trehanpati N, Kumar A, Sharma BC, Sakhuja P, Sarin SK. Granulocyte colony-stimulating factor mobilizes CD34(+) cells and improves survival of patients with acute-on-chronic liver failure. Gastroenterology. 2012 Mar;142(3):505-512.e1. doi: 10.1053/j.gastro.2011.11.027. Epub 2011 Nov 23. |
| 26256891 | Background | Chavez-Tapia NC, Mendiola-Pastrana I, Ornelas-Arroyo VJ, Norena-Herrera C, Vidana-Perez D, Delgado-Sanchez G, Uribe M, Barrientos-Gutierrez T. Granulocyte-colony stimulating factor for acute-on-chronic liver failure: systematic review and meta-analysis. Ann Hepatol. 2015 Sep-Oct;14(5):631-41. |
| Nov 1, 2023 |
| 7 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |