Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia

Launched by HOLTERMAN, AI-XUAN, M.D. · May 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Granulocyte-Colony Stimulating Factor (GCSF) to see if it can help improve the health outcomes of infants diagnosed with biliary atresia, a condition that affects the liver and bile ducts. The trial is looking at two groups of patients: those who have undergone a specific surgery called the Kasai procedure and those who have not. Researchers will be following the participants for two years to assess the safety and effectiveness of GCSF.

To be eligible for this trial, infants must be between 14 and 180 days old, show signs of biliary atresia, and meet certain medical criteria, such as specific bilirubin levels in their blood. However, infants with severe health issues, recent liver transplant needs, or certain other medical conditions will not be able to participate. Families participating in the trial can expect regular check-ups and monitoring over the two years. This study is currently recruiting participants, and it aims to provide valuable information that could improve treatment for biliary atresia in the future.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. preliminary work up for cholestasis suspected or inconclusive diagnosis of BA.
• • 2. Serum Direct bilirubin \> 2 mg/dl,GGT\> 100 U/L
• • 3. Male or female infants with a gestational age\> 36 weeks
• • 4. Admission weight \> 2 kg
• • 5. Age \> 14 days - 180 days at diagnosis
• • 6. For Kasai operated subjects, Type 3 or 4 anatomy of BA
• • 7. For Kasai operated subjects, cholangiogram (if performed) diagnostic of BA
• • 8. Liver biopsy supporting BA diagnosis
• • Exclusion criteria
• • 1. Patients having access to liver transplantation for immediate liver failure
• • 2. Prior Kasai patients
• • 3. Major cardiac, renal, central nervous system (CNS) malformations
• • 4. Intracranial hemorrhage
• • 5. History of recent total parenteral nutrition (TPN) use within the last 2 weeks
• • 6. Gl tract obstruction
• • For Kasai-operated subjects: Type 1 or 2 biliary atresia anatomy
• • 7. Current systemic infection
• • 8. WBC \> 20,000 cells/uL
• • 9. Platelet count \< 20,000 cells/uL or \>1 million cells/uL
• • 10. Concurrent respiratory, metabolic, neurological, cardiovascular, metabolic, and renal illness
• • 11. Elevated serum creatinine \> 1 mg/dL
• • 12. Purpura fulminans or unexplained vascular thrombosis