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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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ChiCTR |
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Last refreshed on:
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26 March 2018 |
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Main ID: |
ChiCTR1800015250 |
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Date of registration:
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2018-03-19 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial
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Scientific title:
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The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial |
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Date of first enrolment:
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2018-01-01 |
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Target sample size:
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high-dose:100;low-dose:100; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=25634 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Jiang Jing-ying
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Address:
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399 Wanyuan Road, Minhang District, Shanghai, China
201102
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Telephone:
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+86 13795383323 |
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Email:
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jocelyn_17@163.com |
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Affiliation:
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Children's Hospital of Fudan University |
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Name:
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Zheng Shan
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Address:
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399 Wanyuan Road, Minhang District, Shanghai, China
201102
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Telephone:
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+86 21 64931007 |
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Email:
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szheng@shmu.edu.cn |
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Affiliation:
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Children's Hospital of Fudan University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) within 72 hours after Kasai procedure for type III biliary atresia;
2) The gestational age at birth is = 36 weeks, male or female;
3) Weight = 2kg when selected;
4) Family members understand and sign informed consent before or during Kasai surgery.
Exclusion criteria: 1) There is a known immune deficiency;
2) Severe surgical complications (such as intestinal obstruction, massive bleeding, etc.) occur within 72 hours after surgery or within the postoperative period;
3) With diabetes or high blood pressure (systolic blood pressure persists =112mmHg);
4) Hemolytic jaundice, ie indirect bilirubin = 85.5 µmol/L (5 mg/dL) within 4 weeks of birth, or indirect bilirubin = 119.7 µmol/L (7 mg/dL) during 4-8 weeks of birth;
5) The mother suffers from human immunodeficiency disease, or is positive for HBsAg, or is positive for hepatitis C virus;
6) Incorporate other infections (such as herpes simplex virus, Toxoplasma gondii, etc.);
7) Severely allergic to steroids or other adjunctive therapies;
8) Consolidate other serious systemic diseases.
Age minimum:
Age maximum:
Gender:
Both
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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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high-dose:UDCA 25mg/kg po;low-dose:UDCA 15mg/kg po;
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Primary Outcome(s)
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jaundice clearance rate ;native liver survival rate;
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Secondary Outcome(s)
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urinary component analysis;native liver survival rate;
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Source(s) of Monetary Support
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Hospital Fund
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Ethics review
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Status: Approved
Approval date: 24/02/2018
Contact:
QIan Li-Ling
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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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