CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Intravenous immunoglobulin (IVIG)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01854827
NCT01854827Phase 2Completed
CompareCT.gov

A Phase 1/2A Trial of Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants With Biliary Atresia

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted May 16, 2013·Updated Oct 1, 2019

In Brief

A Phase 2 clinical trial evaluating Intravenous immunoglobulin (IVIG) for Biliary Atresia. Completed, enrolled 30 participants across 7 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Atresia
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 16, 2013
Enrollment StartOct 1, 2013
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.1 years ago

Interventions

Intravenous immunoglobulin (IVIG)drug

All participants will receive the same dose of IVIG at the same intervals in an open-label fashion as long as the subject does not have any increased risk for toxicity for any IVIG infusion. IVIG will be initiated on day 3 (up to day 5) after HPE surgery (HPE is day 0) at a dose of 1 gm/kg body weight by slow intravenous infusion over at least 4 hours. The same dose (1 gm/kg) and duration of infusion will be repeated on day 30 and day 60 after HPE.