Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia
Status unconfirmed · Phase 2
Conditions studied: Biliary Atresia
In brief
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 GCSF in each of the 2 groups of newly diagnosed BA patients: KBA (i.e., Kasai-operated) or NoK (i.e., patients who did not undergo Kasai surgery). Subjects who participate in the trial will be followed for 2 years.
Key facts
- Study ID
- NCT04373941
- Run by
- Holterman, Ai-Xuan, M.D.
- People needed
- 400
- Starts
- 2023-09-01
- Expected to finish
- 2025-10-31
- Last updated by the study team
- 2023-09-08
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nation Children's Hospital — Hanoi, Dong Da District, Vietnam (enrolling)
- Oregon Health & Science University (OHSU) — Portland, Oregon, United States
- Aga Khan University — Karachi, Pakistan
- Children Hospital 1 — Ho Chi Minh City, Vietnam
Full record on ClinicalTrials.gov
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