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

• Status: Enrolling by invitation
• Trial end date: 2022-05-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia
• Collaborator: Dr Cipto Mangunkusumo General Hospital
• Treatments: Lenograstim; Sargramostim

Criteria

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