A Phase I/IIa Trial of Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants with Biliary Atresia

The PRIME study was a multicenter prospective phase I/IIA open label trial, aimed at assessing the feasibility, tolerability, and safety of intravenous immunoglobulin (IVIG) therapy following hepatic portoenterostomy (HPE) in infants with biliary atresia (BA). After enrollment, participants received three intravenous doses of IVIG at designated intervals over the first 60 days following HPE and were followed for 360 days. All infants in this trial were also treated with standardized doses of other routine standard-of-care treatments for BA and this routine clinical care was not modified by participation in this study.