EUCTR2005-001426-84-FR
Active, not recruiting
Phase 1
Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD) - WIL-14
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Wllebrand disease
- Sponsor
- OCTAPHARMA AG
- Enrollment
- 17
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients\<6 years of age at study admission;
- •Defined inherited VWD of any type;
- •DDAVP treatment known or suspected to be inadequate, insufficient or contraindicated;
- •an expected minimum of 5 exposure days to WILATE within 1 year of observation
- •HIV\-1/2 negative
- •Freely given fully informed conset has been obtained from the patient's parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •any haematological disorder other than VWD
- •diagnosis of aquired VWD
- •any known present or past inhibitor activity against VWF or FVIII
- •administration of DDAVP or other blood/plasma products 5 days prior to the 1st WILATE injection
- •administration of acetylsalicylic acid 14 days before treatment with WILATE
- •known history of intolerance towards plasma derived or blood products
- •participation in another clinical study currently or during the past four weeks
Outcomes
Primary Outcomes
Not specified
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