Biliary Atresia: Clinical and Research Challenges for the Twenty-First Century.
Jorge A Bezerra, Rebecca G Wells, Cara L Mack...
https://pubmed.ncbi.nlm.nih.gov/29604222Actively Recruiting
Phase Not Applicable
Age: 20Days - 1Year
All Genders
Healthy Volunteers
ID06708572
Evaluation of the Use of Granulocyte Colony Stimulating Factor (GCSF) in Post Kasai Type 3 Biliary Atresia
Led by National Liver Institute, Egypt · Updated on 2024-12-11
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 days
Participants receive subcutaneous Granulocyte Colony-Stimulating Factor (GCSF) at a daily dose of 10ug/kg for 3 consecutive days, administered within 3-4 days after the Kasai procedure.
1 to 2 visits around the time of the Kasai procedure
Follow-up
Duration - 6 months
Participants are monitored for outcomes including serum total bilirubin levels at 3 months and incidence of cholangitis at 6 months after treatment.
Visits at 3 months and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
National Liver Institute
Cairo, Menofia Governorate, Egypt, 32511
Actively Recruiting
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Research Team
M
Marwa Narwa Foad Asker, master
B
Behairy Behairy El Sayed Behairy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Contribution of Resident Stem Cells to Liver and Biliary Tree Regeneration in Human Diseases.
Diletta Overi, Guido Carpino, Vincenzo Cardinale...
https://pubmed.ncbi.nlm.nih.gov/30257529Diagnostic Tools for Early Detection of Biliary Atresia: Is a Newborn Screen Attainable?
Michelle M Corrado, Cara L Mack
https://pubmed.ncbi.nlm.nih.gov/35106146