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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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19 February 2015 |
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Main ID: |
NCT01800435 |
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Date of registration:
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15/02/2013 |
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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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A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
BPATXAS |
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Scientific title:
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Whole Blood Clot Stability and Thrombin Generating Capacity Following Treatment With Bypassing Agents (BPA) With and Without and Tranexamic Acid (TXA) in Haemophilia A Patients With inhibitor-an In-vivo Prospective Crossover Study |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01800435 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Norway
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Contacts
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Name:
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PÅL A Holme, 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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Oslo University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Haemophilia patients with high titer inhibitors or high-responding inhibitors, aged
between 18-65 and no history of aspirin or NSAID use within the last 14 days were
eligible for the study.
Exclusion Criteria:
- Patients with renal failure, liver disease, infected with immune deficiency virus
(HIV), platelet count <150x109/L, acquired haemophilia, ongoing bleeding,
hypersensitivity to TXA or a history of arterial or venous thrombosis were excluded
from the study.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hereditary Factor VIII Deficiency Disease With Inhibitor
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Intervention(s)
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Drug: aPCC, aPCC + TXA
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Drug: rFVIIa, rFVIIa + TXA
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Primary Outcome(s)
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Clot stability and thrombin generation capacity following treatment with bypassing agents with and without tranexamic acid.
[Time Frame: 2 years]
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Secondary Outcome(s)
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DIC or thrombosis events associated with different treatment regimens.
[Time Frame: 2 years]
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Secondary ID(s)
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EudraCTnr. 2010-022668-11
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2010-022668-11
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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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