CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE

• Conditions: Inherited von Willebrand Disease; MedDRA version: 8.0Level: PTClassification code 10047715

• Registration Number: EUCTR2005-001426-84-CZ
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Defined inherited VWD of any type.
Age <6 years at study admission.
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 consent has been obtained from the patient's parents (in accordance with local laws, the informed consent of both parents might be necessary).
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any haematological disorder other than VWD.
Diagnosis of acquired 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified