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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03395028 |
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Date of registration:
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22/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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GCSF Adjunct Therapy for Biliary Atresia
BA_GCSF |
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Scientific title:
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Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia |
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Date of first enrolment:
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January 15, 2018 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03395028 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Vietnam
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Contacts
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Name:
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Evan P Nadler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's National Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Completed the preliminary work up for cholestasis with suspected or inconclusive
diagnosis of BA
2. Gestational Age > 36wks
3. Weight > 2 Kg
4. Age >-2 weeks-<180 days at diagnosis
5. Serum Direct Bilirubin > 2 mg/dL GGT > 100 U/L
6. Kasai operated patients for Type 3 or 4 anatomy of BA
7. Cholangiogram/porta hepatis findings diagnostic of BA
8. Liver biopsy supporting BA diagnosis
Exclusion Criteria:
1. Having access to liver transplantation for immediate Kasai failure
2. Prior Kasai patients
3. Major cardiac, renal, CNS malformations with poor prognosis
4. Intracranial hemorrhage
5. History of recent TPN use within the last 2 weeks of surgery
6. GI tract obstruction
7. Laparoscopic Kasai repair
Age minimum:
N/A
Age maximum:
180 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Biliary Atresia
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Intervention(s)
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Drug: Granulocyte Colony-Stimulating Factor
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Primary Outcome(s)
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Dose determination GCSF
[Time Frame: 13 months]
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Secondary ID(s)
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CR00005169
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IND 119679-0007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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