Status:
UNKNOWN
Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia
Lead Sponsor:
Holterman, Ai-Xuan, M.D.
Collaborating Sponsors:
T Rose Clinical, Inc.
Big Leap Research
Conditions:
Biliary Atresia
Eligibility:
All Genders
14-180 years
Phase:
PHASE2
Brief Summary
The Investigators propose to test the hypothesis that GCSF enhances the clinical outcome of biliary atresia in a multi-institutional Phase 2 trial to prospectively evaluate the safety and efficacy of ...
Detailed Description
This is a prospective, randomized, multi-institutional trial in KBA and NoK subjects to be conducted under a Food and Drug Administration approved Investigational New Drug application. The KBA group ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- preliminary work up for cholestasis suspected or inconclusive diagnosis of BA.
- Serum Direct bilirubin \> 2 mg/dl,GGT\> 100 U/L
- Male or female infants with a gestational age\> 36 weeks
- Admission weight \> 2 kg
- Age \> 14 days - 180 days at diagnosis
- For Kasai operated subjects, Type 3 or 4 anatomy of BA
- For Kasai operated subjects, cholangiogram (if performed) diagnostic of BA
- Liver biopsy supporting BA diagnosis
- Exclusion criteria
- Patients having access to liver transplantation for immediate liver failure
- Prior Kasai patients
- Major cardiac, renal, central nervous system (CNS) malformations
- Intracranial hemorrhage
- History of recent total parenteral nutrition (TPN) use within the last 2 weeks
- Gl tract obstruction
- For Kasai-operated subjects: Type 1 or 2 biliary atresia anatomy
- Current systemic infection
- WBC \> 20,000 cells/uL
- Platelet count \< 20,000 cells/uL or \>1 million cells/uL
- Concurrent respiratory, metabolic, neurological, cardiovascular, metabolic, and renal illness
- Elevated serum creatinine \> 1 mg/dL
- Purpura fulminans or unexplained vascular thrombosis
Exclusion
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04373941
Start Date
September 1 2023
End Date
October 31 2025
Last Update
September 8 2023
Active Locations (4)
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1
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
2
Aga Khan University
Karachi, Pakistan
3
Nation Children's Hospital
Hanoi, Dong Da District, Vietnam
4
Children Hospital 1
Ho Chi Minh City, Vietnam