Clinical trialNCT01854827CompletedPhase 1/PHASE2Interventional

Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment30Biliary Atresia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after hepatic portoenterostomy (HPE) for biliary atresia, as well as investigate preliminary evidence of activity and explore mechanisms of action.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Averell Sherker, MD
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
Study Director
clinicaltrials.gov ↗
Ed Doo, MD
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
Study Director
clinicaltrials.gov ↗
Ronald Sokol, MD
Children's Hospital Colorado
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Hospital for Sick Children
Toronto, Ontario, Canada

United States

Children'S Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Children'S Healthcare of Atlanta
Atlanta, Georgia, United States
Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children'S Hospital at Pittsburgh
Pittsburgh, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Intravenous immunoglobulin

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2013
Primary completion: 31 Jul 2016
Completion: 31 Jul 2016
Last update posted: 1 Oct 2019
Registered enrollment: 30
Registry id: NCT01854827

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.