Study protocol of Phase 2 open-label multicenter randomized controlled trial for granulocyte-colony stimulating factor (GCSF) in post-Kasai Type 3 biliary atresia

Multicenter phase 2 RCT testing whether GCSF administered immediately post-Kasai improves bile flow and reduces bilirubin levels in neonates with type 3 biliary atresia. Study aims to enroll 218 subjects across Vietnam, Pakistan, and US sites to evaluate GCSF as affordable adjunct therapy that may reduce cholangitis and improve transplant-free survival in resource-limited settings.