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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: |
NCT01854827 |
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Date of registration:
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27/09/2012 |
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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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Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
PRIME |
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Scientific title:
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A Phase 1/2A Trial of Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants With Biliary Atresia |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01854827 |
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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: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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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 Disease (NIDDK) |
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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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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:
- Infant under 120 days old with established diagnosis of BA. Subjects in this trial
must start treatment within 3-5 days of the Kasai procedure and be part of a
prospective study of the natural history of biliary atresia also being conducted by
ChiLDREN (http://www.clinicaltrials.gov/ct/show/NCT00061828?order=3).
- Standard HPE operation has been performed for BA within the previous 3 days
- Post-conception age = 36 weeks at time of enrollment
- Weight at enrolment = 2000 gm
- Written informed consent to participate in the study obtained within 3 days of
completion of HPE.
Exclusion Criteria:
- Laparoscopic HPE or "gall bladder Kasai" (cholecysto-portostomy) surgery was performed
- Biliary atresia splenic malformation syndrome (presence of asplenia, polysplenia or
double spleen)
- History of a hypercoagulable disorder
- Renal Disease defined as serum creatinine > 1.0 mg/dl prior to enrollment or presence
of complex renal anomalies found on imaging
- Evidence of congestive heart failure or fluid overload
- Presence of significant systemic hypertension for age (defined as persistent systolic
blood pressure =112 mmHg measured on at least 3 occasions following HPE)
- Infants whose mother is known to have human immunodeficiency virus infection
- Infants whose mother is known to be serum HBsAg or hepatitis C virus antibody positive
- Previous treatment with intravenous immunoglobulin therapy or corticosteroid therapy
- Previous treatment with any other investigational agent
- History of allergic reaction to any human blood product infusion
- 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 IVIG
Age minimum:
N/A
Age maximum:
120 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: Intravenous immunoglobulin (IVIG)
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Primary Outcome(s)
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Adverse Events
[Time Frame: 360 days post-HPE]
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Feasibility of IVIG Treatment
[Time Frame: 60 days post-HPE]
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Acceptability of IVIG
[Time Frame: 60 days post-HPE]
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Serious Adverse Events
[Time Frame: 360 days post-HPE]
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Level 3-5 Toxicity
[Time Frame: 360 days post-HPE]
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Secondary Outcome(s)
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Circulating Regulatory T-Cells, Inflammatory Cytokines, and Specific Autoantibodies.
[Time Frame: Over 360 days after HPE]
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Good Bile Drainage at 360 Days Post-HPE
[Time Frame: 360 days post-HPE]
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Good Bile Drainage at 90 Days Post-HPE
[Time Frame: 90 days post-HPE]
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Transplant-free Survival
[Time Frame: 360 days post-HPE]
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Good Bile Drainage at 180 Days Post-HPE
[Time Frame: 180 days post-HPE]
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Secondary ID(s)
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U01DK062456
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P007 PRIME
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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