Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04113317
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2019-09-22
Brief Title:
Granulocyte-Colony Stimulating Factor G-CSF as Optimizing Therapy for Pediatric Liver Transplantation
Sponsor:
Fakultas Kedokteran Universitas Indonesia
Organization:
Fakultas Kedokteran Universitas Indonesia
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 5μgkgday 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 2000
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 2000
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None