Status:
COMPLETED
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Biliary Atresia
Eligibility:
All Genders
3-120 years
Phase:
PHASE1
PHASE2
Brief 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 admin...
Detailed Description
In this multicenter prospective phase 1/2A open label trial, the feasibility, tolerability and safety of intravenous immunoglobulin (IVIG) therapy following hepatic portoenterostomy (HPE) will be asse...
Eligibility Criteria
Inclusion
- Infant under 120 days old with established diagnosis of BA. Subjects in this trial must start treatment within 3-5 days of the Kasai procedure and be part of a prospective study of the natural history of biliary atresia also being conducted by ChiLDREN (http://www.clinicaltrials.gov/ct/show/NCT00061828?order=3).
- Standard HPE operation has been performed for BA within the previous 3 days
- Post-conception age ≥ 36 weeks at time of enrollment
- Weight at enrolment ≥ 2000 gm
- Written informed consent to participate in the study obtained within 3 days of completion of HPE.
Exclusion
- Laparoscopic HPE or "gall bladder Kasai" (cholecysto-portostomy) surgery was performed
- Biliary atresia splenic malformation syndrome (presence of asplenia, polysplenia or double spleen)
- History of a hypercoagulable disorder
- Renal Disease defined as serum creatinine \> 1.0 mg/dl prior to enrollment or presence of complex renal anomalies found on imaging
- Evidence of congestive heart failure or fluid overload
- Presence of significant systemic hypertension for age (defined as persistent systolic blood pressure ≥112 mmHg measured on at least 3 occasions following HPE)
- Infants whose mother is known to have human immunodeficiency virus infection
- Infants whose mother is known to be serum HBsAg or hepatitis C virus antibody positive
- Previous treatment with intravenous immunoglobulin therapy or corticosteroid therapy
- Previous treatment with any other investigational agent
- History of allergic reaction to any human blood product infusion
- Infants with other severe concurrent illnesses, such as neurological, cardiovascular, pulmonary, metabolic, endocrine, and renal disorders, that would interfere with the conduct and results of the study
- Any other clinical condition that is a contraindication to the use of IVIG
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01854827
Start Date
October 1 2013
End Date
July 1 2016
Last Update
October 1 2019
Active Locations (7)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
4
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229