Status:
COMPLETED
A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
Lead Sponsor:
Oslo University Hospital
Conditions:
Hereditary Factor VIII Deficiency Disease With Inhibitor
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief Summary
Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients with high titer inhib...
Detailed Description
Patients receive the first day aPCC (75IU/kg) and aPCC in addition to TXA (20mg/kg orally) the second day. After a 14 days washout period they crosse over using rFVIIa (90 µg/kg) otherwise the same ex...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01800435
Start Date
October 1 2011
End Date
October 1 2012
Last Update
March 1 2013
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424