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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001426-84-DE

Enrollment

Registered

2005-10-21

Start date

2006-02-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inherited von Willebrand Disease MedDRA version: 8.0 Level: PT Classification code 10047715

Interventions

Trade Name: WILATE Product Name: Wilate Pharmaceutical Form: Powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Defined inherited VWD of any type. Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this clinical study is to assess the efficacy of WILATE for the prevention and/or treatment of bleedings, and in surgical procedures.;Secondary Objective: Secondary objectives are the determination of inhibitors to VWF and FVIII and to assess the clinical safety and tolerability of treatment with WILATE. Recovery assessment will be performed in patients undergoing a major surgery.;Primary end point(s): Efficacy of WILATE in prevention (prophylactic treatment) and/or treatment of bleeding episodes measured by: the number of bleedings, amount of IMP required (consumption of WILATE), number of exposures necessary to stop bleedings, assessment of response to treatment of bleeding episodes. Overall efficacy will be recorded using a 4-point verbal rating scale (VRS). The details of all treatments and bleedings will be documented. Efficacy of WILATE in surgical procedures measured by: amount of IMP used , haemostasis reached, loss of blood (intra- and postoperatively), the requirements of additional blood or plasma transfusions. Overall efficacy will be recorded using a 4-point verbal rating scale (VRS). Details of all treatments and characteristics of the surgical procedures will be documented.	—

Measure

Time frame

Main Objective: The primary objective of this clinical study is to assess the efficacy of WILATE for the prevention and/or treatment of bleedings, and in surgical procedures.;Secondary Objective: Secondary objectives are the determination of inhibitors to VWF and FVIII and to assess the clinical safety and tolerability of treatment with WILATE. Recovery assessment will be performed in patients undergoing a major surgery.;Primary end point(s): Efficacy of WILATE in prevention (prophylactic treatment) and/or treatment of bleeding episodes measured by: the number of bleedings, amount of IMP required (consumption of WILATE), number of exposures necessary to stop bleedings, assessment of response to treatment of bleeding episodes. Overall efficacy will be recorded using a 4-point verbal rating scale (VRS). The details of all treatments and bleedings will be documented. Efficacy of WILATE in surgical procedures measured by: amount of IMP used , haemostasis reached, loss of blood (intra- and postoperatively), the requirements of additional blood or plasma transfusions. Overall efficacy will be recorded using a 4-point verbal rating scale (VRS). Details of all treatments and characteristics of the surgical procedures will be documented.

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Countries

Czech Republic, France, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026