Trial reportJournal of pediatric gastroenterology and nutrition2019
A Phase I/IIa Trial of Intravenous Immunoglobulin Following Portoenterostomy in Biliary Atresia.
Trial report in Journal of pediatric gastroenterology and nutrition, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01854827 (A Phase 1/2A Trial of Intravenous Immunoglobulin), which is not on this map. Cited by 25 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2A Trial of Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants With Biliary Atresia
Who cites it
25 citing papers in PubMed, 36 citations in OpenAlex.
- Effects of post-hepatic portoenterostomy adjuvant therapy on liver transplantation in children with biliary atresia: A systematic review.JPGN reports · 2026Article
- Rectal budesonide: A potential game changer after Kasai hepatoportoenterostomy.Journal of pediatric gastroenterology and nutrition · 2025Article
- Recent advances in the management of pediatric cholestatic liver diseases.Journal of pediatric gastroenterology and nutrition · 2025Review
- Heritable Chronic Cholestatic Liver Diseases: A Review.Journal of clinical and translational hepatology · 2024Review
- Biliary atresia.Nature reviews. Disease primers · 2024Review
- Galectin-3 in biliary atresia and other pediatric cholestatic liver diseases.Hepatology research : the official journal of the Japan Society of Hepatology · 2024Article
- Diseases of bile duct in children.World journal of gastroenterology · 2024Review
- Biliatresone induces cholangiopathy in C57BL/6J neonates.Scientific reports · 2023Article
- Editorial: Elimination of biliary atresia.Frontiers in pediatrics · 2023Article
- Cellular Therapies in Pediatric Liver Diseases.Cells · 2022Review
- Biliary Atresia in Children: Update on Disease Mechanism, Therapies, and Patient Outcomes.Clinics in liver disease · 2022Review
- Current and emerging adjuvant therapies in biliary atresia.Frontiers in pediatrics · 2022Review
- Review
- Analysis of Cholangitis Rates with Extended Perioperative Antibiotics and Adjuvant Corticosteroids in Biliary Atresia.Pediatric gastroenterology, hepatology & nutrition · 2021Article
- Modeling Outcomes in Children With Biliary Atresia With Native Liver After 2 Years of Age.Hepatology communications · 2020Article
- Intravenous Immune Globulin Uses in the Fetus and Neonate: A Review.Antibodies (Basel, Switzerland) · 2020Review
- Ileal bile acid transporter inhibition as an anticholestatic therapeutic target in biliary atresia and other cholestatic disorders.Hepatology international · 2020Review
- Adjuvant treatments for biliary atresia.Translational pediatrics · 2020Review
- The relative abundance of monocyte subsets determines susceptibility to perinatal hepatic inflammation.Journal of clinical & cellular immunology · 2020Article
- Pediatric Cholestatic Liver Disease: Review of Bile Acid Metabolism and Discussion of Current and Emerging Therapies.Frontiers in medicine · 2020Review
Corrections and comments
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Authors and funding
15 authors at 10 institutions in 2 countries.
Funding
Abstract
objectivesBiliary atresia (BA) is a progressive neonatal fibroinflammatory cholangiopathy. We hypothesized that intravenous immunoglobulin (IVIg) would be safe, feasible, acceptable, and efficacious for the treatment of BA. The primary objective of this study was to establish the feasibility, acceptability, and safety profile of IVIg administration after hepatoportoenterostomy (HPE) in BA. The secondary objective was to determine the treatment efficacy of IVIg based on good bile drainage and survival with the native liver.
methodsA multicenter, prospective, open-labeled, phase I/IIA trial of IVIg was conducted, with 1 g/kg/dose of IVIg infused at 3-5, 30, and 60 days post-HPE, and subjects followed for 360 days post-HPE. Twenty-nine participants completed the study.
resultsAdministration of IVIg infusions was feasible and acceptable in 79%. None of the serious adverse events (SAEs) were directly related to IVIg infusions; however, 90% of participants had an SAE. Compared with a historical placebo-arm group, there was no significant increase in the proportion of IVIg participants with a serum total bilirubin <1.5 mg/dL at 90, 180, or 360 days post-HPE. Survival with the native liver in the IVIg participants showed no significant benefit over the historical placebo arm, with a difference at 360 days of -11.9% (IVIg: 58.6%, placebo: 70.5%; 90% UCB: 2.1%; P > 0.05).
conclusionsAlthough IVIg infusions in infants with BA post-HPE were feasible, acceptable and safe, there was no trend to lower bilirubin levels or improved 360-day survival with the native liver. CLINICAL TRIAL: Safety Study of Intravenous Immunoglobulin Post-Portoenterostomy in Biliary Atresia; #NCT01854827.
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