EUCTR2010-020113-85-DE
Active, not recruiting
Not Applicable
A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihaemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune Tolerance Induction in Male Paediatric Subjects with Haemophilia A (=2%) who have Developed High-titre Antibodies to Factor VIII (Factor VIII Inhibitors). - SWIFT-ITI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CSL Behring GmbH
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male subjects diagnosed with haemophilia A (::;2% FVIII level in the
- •absence of factor replacement, according to their medical history).
- •2\. Age 28 days to \<12 years.
- •3\. ITI treatment can be initiated if:
- •a. An inhibitor level of \>5 and \<200 BU/mL was confirmed in 2 repeated
- •tests by the central laboratory during the screening period and no
- •waiting period is required as judged by the investigator.
- •b. An inhibitor level of \>5 and \<200 BU/mL was confirmed in 2 repeated
- •tests by the central laboratory during the screening period and the
- •inhibitor titre decreased from the peak titre during a waiting period
Exclusion Criteria
- •Exclusion Criteria:
- •l.DThe subject has received IT! previously.
- •2\.DSubjects with a historical peak inhibitor titre of \~200 BU/mL.
- •3\.DConcomitant treatment with drugs with immunosuppressive side
- •effects (eg, systemic cortlcosteroids), azathioprine, cyclophosphamide,
- •high dose immunoglobulin or the use of a protein A column or
- •plasmapheresis and interferons.
- •4\.DHigh risk of cardiovascular, cerebrovascular, or other
- •thromboembolic events (excluding catheter thrombosis) as judged by
- •the investigator.
Outcomes
Primary Outcomes
Not specified
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