What is Granulocyte Colony Stimulating Factor (GCSF) studying for biliary atresia?

Granulocyte Colony Stimulating Factor (GCSF) is being studied to see how it affects infants with type 3 biliary atresia after the Kasai surgery. Researchers want to understand if GCSF can improve liver function and reduce complications. The study is sponsored by the National Liver Institute, Egypt, focusing on this serious infant liver condition.

Who may be eligible for this biliary atresia clinical trial?

Infants between 20 days and 1 year old with type 3 biliary atresia confirmed by surgery may be eligible. The study includes both boys and girls but excludes those with major heart, kidney, lung, or neurological problems, active infections, or certain blood disorders. Please review eligibility criteria for more details.

Is there any cost to participate in this biliary atresia clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can focus on their care without worrying about study fees.

Actively Recruiting

Phase Not Applicable

Age: 20Days - 1Year

All Genders

Healthy Volunteers

ID06708572

Study of Granulocyte Colony Stimulating Factor GCSF Treatment in Infants with Type 3 Biliary Atresia After Kasai Surgery

Led by National Liver Institute, Egypt · Updated on 2024-12-11

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Granulocyte Colony Stimulating Factor GCSF in infants with type 3 biliary atresia after the Kasai procedure. Biliary atresia is a serious liver condition in infants causing bile duct damage and blockage, often leading to liver failure and the need for transplantation. This study aims to assess how GCSF affects clinical and biochemical outcomes in this population, focusing on liver health and disease progression. Participants will be divided into two groups one group of 20 infants will receive subcutaneous GCSF at a dose of 10 micrograms per kilogram daily for three days, starting 3 to 4 days after the Kasai surgery, while the other group of 20 infants will not receive GCSF. The study compares these two groups to see if GCSF helps improve liver function and reduce complications related to biliary atresia. During the study, researchers will monitor participants for changes in total bilirubin levels at three months and the frequency of cholangitis episodes at six months. Various clinical and laboratory assessments will be conducted to evaluate liver function and inflammation. The study will continue until October 2026, with regular follow-ups to observe the infants health and disease outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Days - 1Year

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Infants diagnosed with biliary atresia having a biliary atresia score greater than 23.927
Diagnosis confirmed as type 3 biliary atresia by liver histology and intra-operative findings
Infants allocated for Kasai porto-enterostomy with intra-operative cholangiogram confirming type 3 anatomy

You will not qualify if you...

Major cardiac, renal, pulmonary, or neurological malformations or illnesses
Hemoglobinopathies such as sickle cell anemia
Active systemic infection
White blood cell count greater than 20,000 cells/mm3
Platelet count less than 40,000 cells/mm3 or equal to or greater than 800,000 cells/mm3
Purpura fulminans or unexplained vascular thrombotic conditions

Research Team

Marwa Narwa Foad Asker, master

Behairy Behairy El Sayed Behairy, MD

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