Ms Martina Jansen
+43 (0)1 61032 1208
Comparison of pharmacokinetics of Wilate® and Haemate® P in von Willebrand type 3 patients.
Ethics approval received from:
1. Ethics Committee of SHAT "Joan Pavel" OOD hospital, Sofia on the 15th July 2008
2. Ethics Committee of FNsP Cyril and Method Hospital, Bratislava on the 24th June 2008
Prospective, randomised, controlled, open-labelled, two-arm cross-over, multi-centre phase II study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request patient information material
von Willebrand disease
1. Wilate® vials of approximately 400 IU VWF:RCo
2. Haemate® P vials of approximately 500 VWF:RCo
One vial of freeze-dried concentrate is reconstituted in 0.1% polysorbate 80 solution/water for injection. A dose of at least 40 IU VWF:RCo/kg body weight will be given intravenously by bolus administration. Each product is administered once. Blood samples will be taken at the following time-points after each infusion: 30 minutes before and at 15 minutes, 30 minutes, 45 minutes, 1, 3, 6, 12, 24, 30, 48, and 72 hours after the infusion.
Wilate®, Haemate® P
Primary outcome measures
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).
Outcomes will be determined from plasma levels measured from samples taken at the above mentioned time-points.
Secondary outcome measures
1. Pharmacokinetics: the following parameters are secondary endpoints and will be calculated for VWF:RCo, FVIII:C, VWF:Ag and VWF:CB:
1.1. Area under the curve (AUC)
1.2. Maximum plasma concentration (Cmax)
1.3. Time to reach maximum plasma concentration (Tmax)
1.4. Mean residence time (MRT)
1.5. Volume of distribution (Vd)
1.6. Clearance (Cl)
For the calculation of these parameters, the labelled potency of the respective drug will be the taken. Outcomes will be determined from plasma levels measured from samples taken at the above mentioned time-points.
2. Recovery: in vivo incremental recovery of VWF:RCo, FVIII:C, VWF:Ag and VWF:CB will be calculated from the levels before and after the injection. For the calculation of recovery, the labelled potency of the respective drug will be the taken.
3. Tolerability: tolerability will be assessed by monitoring vital signs, haematological parameters (red blood cell [RBC] count, white blood cell [WBC] count, haemoglobin, haematocrit [HCT], and platelet count [PC]), and by monitoring adverse events (AEs)
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Octapharma AG (Switzerland)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting