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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: |
NCT00294684 |
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Date of registration:
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21/02/2006 |
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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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A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy
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Scientific title:
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A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants With Biliary Atresia |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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141 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00294684 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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John Magee, 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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University of Michigan Medical Center, Ann Arbor |
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Name:
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Ronald Sokol, 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 Hospital Colorado |
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Name:
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Averell Sherker, 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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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Name:
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Ed Doo, 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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National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Portoenterostomy or gall bladder Kasai operation for biliary atresia within the
previous 72 hours
- Post-conception age = 36 weeks
- Weight at enrolment = 2000 gm
- Written informed consent to participate in the study obtained prior to or within 72
hours of completion of portoenterostomy. (Note: Families of potential subjects may be
approached prior to the portoenterostomy.)
Exclusion Criteria:
- Known immunodeficiency
- Diabetes mellitus
- Presence of significant systemic hypertension for age (persistent systolic blood
pressure =112 mmHg)
- A serum indirect (unconjugated) bilirubin = 5 mg/dL for infants under 4 weeks of age
or = 7 mg/dL for infants between 4 and 8 weeks of age
- Known sensitivity to corticosteroids
- Documented bacteremia or other tissue infection which is felt to be clinically
relevant
- Known congenital infection or disease with herpes simplex virus, toxoplasmosis, or
cytomegalovirus inclusion disease of the liver
- Infants whose mother is known to have human immunodeficiency virus infection
- Infants whose mother is known to be HBsAg or hepatitis C virus positive
- Infants with other severe concurrent illnesses such as neurological, cardiovascular,
pulmonary, metabolic, endocrine, and renal disorders that would interfere with the
conduct and results of the study
- Any other clinical condition that is a contraindication to the use of corticosteroid
(e.g., bowel perforation)
- Infants who have received the live attenuated rotavirus vaccine (e.g., Rotateq) within
5 days prior to proposed administration of study drug
Age minimum:
N/A
Age maximum:
6 Months
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: Placebo
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Drug: Corticosteroids
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Primary Outcome(s)
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The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy
[Time Frame: Measurements will be made at 6 months after portoenterostomy]
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Secondary Outcome(s)
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Total Bilirubin Concentration at 12 Months
[Time Frame: 12 Months post HPE]
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Presence of Ascites at 24 Months
[Time Frame: 24 Months]
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Survival With Native Liver at 24 Months of Age
[Time Frame: Measurements will be made at 24 months of age]
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Serum Total Bilirubin Concentration
[Time Frame: Measurements will be made at 3 months after portoenterostomy]
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Height Z-Score
[Time Frame: HPE to age 24 Months]
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Presence of Ascites at 12 Months
[Time Frame: 12 Months]
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Weight Z-Score
[Time Frame: HPE until 24 months of age]
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Total Bilirubin Concentration at 24 Months of Age
[Time Frame: At 24 Months of Age]
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Secondary ID(s)
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U01DK062456
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CHILDREN (START) (IND)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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