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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: |
NCT01580670 |
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Date of registration:
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03/04/2012 |
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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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Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
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Scientific title:
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Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01580670 |
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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 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kazuoki Kondo, 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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Mitsubihsi Tanabe Pharma Corporation |
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Name:
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Toshifumi Hibi, 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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Kitasato University Kitasato Institute Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have been diagnosed as Crohn's disease at least 3 months prior to
screening.
- Have active Crohn's disease despite adequate conventional therapy.
Exclusion Criteria:
- Patients with severe intestinal strictures (strictures which may affect the number of
defecations, etc., or dilation of the colon or strictures in the proximal small bowel
observed on barium radiograph, or strictures precluding the insertion of endoscope), a
diagnosis of short bowel syndrome, or previous stoma surgery.
- Patients who have a history of treatment with infliximab, or biological products
(anti-TNFa agents and anti-IL-6 agents, etc.).
Age minimum:
6 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pediatric Crohn's Disease
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Intervention(s)
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Drug: TA-650
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Primary Outcome(s)
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Percent of Patients Who Achieved PCDAI Response
[Time Frame: Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54]
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Secondary Outcome(s)
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Change From Baseline of PCDAI Score
[Time Frame: Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54]
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PCDAI Score
[Time Frame: Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54]
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The Percent of the Patients Who Experienced an Adverse Event
[Time Frame: Until the last time point during the period from administration of the study drug to Week 54]
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Percent of Patients Who Achieved PCDAI-Based Remission Rate.
[Time Frame: Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54]
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Serum TA-650 Concentration
[Time Frame: After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration.]
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Secondary ID(s)
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TA-650-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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