Status:
COMPLETED
GCSF Adjunct Therapy for Biliary Atresia
Lead Sponsor:
Holterman, Ai-Xuan, M.D.
Collaborating Sponsors:
T. Rose Clinical, Inc., United States
Children's National Research Institute
Conditions:
Biliary Atresia
Eligibility:
All Genders
2-180 years
Phase:
EARLY_PHASE1
Brief Summary
The Investigators propose to test the hypothesis that GCSF therapy enhances the clinical outcome of Kasai operated Biliary Atresia (BA) patients. In this study, Investigators will conduct a dose deter...
Detailed Description
In BA, neonatal fibrous obliteration of the biliary tract obstructs biliary drainage and promotes biliary fibrosis. BA is the leading cause of pediatric chronic end-stage liver disease and pediatric l...
Eligibility Criteria
Inclusion
- Completed the preliminary work up for cholestasis with suspected or inconclusive diagnosis of BA
- Gestational Age \> 36wks
- Weight \> 2 Kg
- Age \>-2 weeks-\<180 days at diagnosis
- Serum Direct Bilirubin \> 2 mg/dL GGT \> 100 U/L
- Kasai operated patients for Type 3 or 4 anatomy of BA
- Cholangiogram/porta hepatis findings diagnostic of BA
- Liver biopsy supporting BA diagnosis
Exclusion
- Having access to liver transplantation for immediate Kasai failure
- Prior Kasai patients
- Major cardiac, renal, CNS malformations with poor prognosis
- Intracranial hemorrhage
- History of recent TPN use within the last 2 weeks of surgery
- GI tract obstruction
- Laparoscopic Kasai repair
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03395028
Start Date
January 15 2018
End Date
January 31 2020
Last Update
February 17 2020
Active Locations (2)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
National Childrens Hospital
Hanoi, Vietnam