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

Phase 1

• Conditions: Wllebrand disease; MedDRA version: 8.1Level: PTClassification code 10047715Term: Von Willebrand's disease

• Registration Number: EUCTR2005-001426-84-FR
• Lead Sponsor: OCTAPHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-23
• Study Completion: 2009-08-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17

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
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 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

Study & Design

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