Pharmacokinetics of Wilate® and Haemate® P in von Willebrand type 3 patients: a prospective, randomised, controlled, open-labelled, two-arm cross-over study

Phase 2

Completed

• Conditions: von Willebrand disease; Haematological Disorders; Other coagulation defects

• Registration Number: ISRCTN12436735
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-04
• Study Completion: 2008-11-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Defined inherited von Willebrand disease (VWD) type 3
2. Male or female subject of at least 12 years of age and have a body weight of at least 32 kg but not more than 125 kg
3. Negative for hepatitis B surface antigen (HBsAg)
4. For human immunodeficiency virus (HIV)-positive subjects: must have a baseline CD4+ cell count of greater than 200/mm^3, and a platelet count of greater than 100,000/dL
5. Freely given written informed consent. For subjects who are not legally permitted to provide written consent, the consent must be provided by parents or legal guardians.
6. Females must promise to avoid becoming pregnant for visits 1 to 11

Exclusion Criteria

1. Subjects with any other bleeding disorders
2. Known history of intolerance to plasma derivatives or blood products
3. Present or past inhibitor activity directed against any von Willebrand factor (VWF)/coagulation factor eight (FVIII) component
4. Severe liver or kidney disease
5. Participation in another clinical study involving an investigational treatment, either currently or within the 4 weeks prior to study entry. Studies consisting of data and blood sampling collections on a regular or long-term basis are exempt from this exclusion.
6. Subjects with excessive alcohol or illicit drug usage
7. Subjects who cannot comply with protocol requirements
8. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The in-vivo half life (t1/2) of Wilate® is the primary endpoint and will be calculated for VWF ristocetin cofactor activity (VWF:RCo), FVIII:C, VWF antigen (VWF:Ag), and VWf collagen binding assay (VWF:CB).<br><br> Outcomes will be determined from plasma levels measured from samples taken at the above mentioned time-points.<br>