Evaluation of the Use of Granulocyte Colony Stimulating Factor (GCSF) in Post Kasai Type 3 Biliary Atresia

Launched by NATIONAL LIVER INSTITUTE, EGYPT · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Granulocyte Colony Stimulating Factor (GCSF) in infants with a condition known as biliary atresia, specifically those who have undergone a procedure called the Kasai porto-enterostomy. Biliary atresia is a serious liver condition that affects newborns, and the trial aims to see how GCSF can improve health outcomes for these patients. The study is currently recruiting participants, and it’s open to infants aged from 20 days to 1 year old who have been diagnosed with type 3 biliary atresia.

To be eligible for the trial, infants must have a specific score indicating the severity of their condition and must have undergone the Kasai surgery with a confirmed type 3 diagnosis. However, infants with serious heart, kidney, or lung problems, certain blood disorders, ongoing infections, or specific blood count issues cannot participate. If enrolled, participants will receive GCSF and will be monitored for their health outcomes to see how effective the treatment is. This trial represents an important step in finding better treatments for children suffering from biliary atresia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants with initial diagnosis of biliary atresia with biliary atresia score \> 23.927 will be allocated for Kasai porto-enterostomy with intra-operative cholangiogram reaching type 3 biliary atresia anatomy as a final diagnosis.
• Exclusion Criteria:
• • Major cardiac, renal, pulmonary, neurological malformations or illnesses.
• • Hemoglobinopathies, such as sickle cell anemia
• • Active systemic infection.
• • White blood cell count \> 20,000 cells/mm3.
• • Platelet count \< 40,000 cells/mm3 or ≥ 800,000 cells/mm3.
• • Purpura fulminans or unexplained vascular thrombotic conditions.