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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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11 April 2016 |
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Main ID: |
NCT01844635 |
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Date of registration:
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29/04/2013 |
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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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Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
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Scientific title:
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A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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320 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01844635 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Seiji Kojima, MD., PhD. |
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Address:
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Telephone:
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+81-52-744-2294 |
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Email:
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kojimas@med.nagoya-u.ac.jp |
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Affiliation:
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Name:
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Seiji Kojima, MD., PhD. |
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Address:
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Telephone:
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+81-52-744-2294 |
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Email:
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kojimas@med.nagoya-u.ac.jp |
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Affiliation:
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Name:
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Seiji Kojima, MD., PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatrics, Nagoya University Graduate School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Acquired aplastic anemia
- Age: younger than 70 years old
- Severity: SAA, VSAA.
- Interval between diagnosis and registration <6 months.
- Written informed consent from the caretakers and/or whenever possible consent from
the patient.
Exclusion Criteria:
Age minimum:
N/A
Age maximum:
69 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acquired Aplastic Anemia.
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Intervention(s)
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Drug: Thymoglobulin
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Primary Outcome(s)
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Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
[Time Frame: day 180 after the start of IST]
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Secondary ID(s)
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APBMT AAWG-01
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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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