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A phase I/IIA trial of intravenous immunoglobulin following portoenterostomy in biliary atresia

Journal of Pediatric Gastroenterology Mar 31, 2019

Mack CL, et al. - In this multicenter, prospective, open-labeled, phase I/IIA trial, researchers identified the feasibility, acceptability, and safety profile of intravenous immunoglobulin (IVIg) administration following hepatoportoenterostomy (HPE) in biliary atresia (BA), a progressive neonatal fibroinflammatory cholangiopathy, and determined the efficacy of IVIg treatment based on good bile drainage and native liver survival. In this study involving 29 participants, 79% of IVIg infusions were feasible and acceptable. Although IVIg infusions were feasible, acceptable and safe in infants with BA post-HPE, there was no trend towards lowering bilirubin levels or improving native liver survival for 360 days. None of the serious adverse events (SAEs) related directly to IVIg infusions, however, 90% of participants had an SAE.
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