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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: |
NCT02250508 |
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Date of registration:
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02/09/2014 |
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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 Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
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Scientific title:
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A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease. |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02250508 |
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Study type:
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Interventional |
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Study design:
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Primary purpose: Treatment.
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Phase:
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Phase 2
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Countries of recruitment
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Israel
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previously treated subjects of at least 12 years of age, with any type of VWD were
eligible for entry into this study.
Exclusion Criteria:
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Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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vonWillebrand's Disease
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Intervention(s)
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Biological: Optivate® (Human Coagulation Factor VIII)
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Biological: Haemate P® (Human Coagulation Factor VIII)
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Primary Outcome(s)
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AUC (0-48h) for VWF: RCo
[Time Frame: Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose]
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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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