Status:
COMPLETED
Granulocyte-Colony Stimulating Factor (G-CSF) as Optimizing Therapy for Pediatric Liver Transplantation
Lead Sponsor:
Fakultas Kedokteran Universitas Indonesia
Collaborating Sponsors:
Dr Cipto Mangunkusumo General Hospital
Conditions:
Liver Cirrhosis
Severe Malnutrition
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04113317
Start Date
January 1 2020
End Date
February 28 2022
Last Update
July 27 2022
Active Locations (1)
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1
Fakultas Kedokteran Universitas Indonesia
Jakarta, Java, Indonesia, 16424