Using GCSF to improve outcomes in infants with biliary atresia after surgery
Evaluation of the Use of Granulocyte Colony Stimulating Factor (GCSF) in Post Kasai Type 3 Biliary Atresia
This study is testing if a treatment called GCSF can help improve recovery and liver function in infants with biliary atresia after their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Days to 1 Year |
| Sex | All |
| Sponsor | National Liver Institute, Egypt Academic / other |
| Locations | 1 site (Cairo, Menofia Governorate) |
| Trial ID | NCT06708572 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of Granulocyte Colony Stimulating Factor (GCSF) on infants diagnosed with type 3 biliary atresia following a Kasai procedure. Biliary atresia is a serious condition that can lead to liver failure, and GCSF is thought to enhance liver regeneration by mobilizing stem cells and promoting healing. The study aims to assess both clinical and biochemical outcomes in these patients to determine the efficacy of GCSF as a treatment option.
Who should consider this trial
Good fit: Ideal candidates are infants diagnosed with type 3 biliary atresia who have undergone a Kasai porto-enterostomy.
Not a fit: Patients with significant comorbidities such as major organ malformations or severe blood disorders may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could improve liver function and reduce the need for liver transplantation in affected infants.
How similar studies have performed: While GCSF has shown promise in other liver injury contexts, this specific application in biliary atresia is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo, Menofia Governorate
- National Liver Institute — Cairo, Menofia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Marwa Narwa Foad Asker, master
- Email: marwafoadali@gmail.com
- Phone: +201008913103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.