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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Biliary Atresia
Interventions
DRUG

Intravenous immunoglobulin (IVIG)

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.

Trial Locations (7)

15213

Children's Hospital at Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

30322

Children's Healthcare of Atlanta, Atlanta

45229

Children's Hospital Medical Center, Cincinnati

80045

Children's Hospital Colorado, Aurora

90027

Children's Hospital Los Angeles, Los Angeles

M5G 1X8

Hospital for Sick Children, Toronto

All Listed Sponsors
lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT01854827 - Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia | Biotech Hunter | Biotech Hunter