A pilot randomised controlled trial to assess the role of G-CSF in Biliary Atresia patients Post Kasai Portoenterostomy

The rationale of conducting this pilot study in India stems from the recognition of disease heterogeneity - a complex interplay of genetics, environmental & geographical factors that can influence the clinical presentation, progression, & treatment response of biliary atresia. While phase 1 trials from other countries have shown promising results, such data cannot be universally extrapolated without contextual validation. Genetic predispositions may be modulated by by local environmental exposures, dietary patterns, healthcare access & endemic pathogens, all of which differ significantly in India. Therefore, this pilot trial aims to generate early evidence of feasibility, safety & biological response specific to Indian Pediatric population, while also addressing the absence of published Phase 2 trial outcomes.