Contact information
Type
Scientific
Primary contact
Ms Martina Jansen
ORCID ID
Contact details
Oberlaaerstrasse 235
Vienna
1100
Austria
+43 (0)1 61032 1208
martina.jansen@octapharma.com
Additional identifiers
EudraCT number
2008-001910-25
ClinicalTrials.gov number
Protocol/serial number
WIL-21
Study information
Scientific title
Acronym
Study hypothesis
Comparison of pharmacokinetics of Wilate® and Haemate® P in von Willebrand type 3 patients.
Ethics approval
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
Study design
Prospective, randomised, controlled, open-labelled, two-arm cross-over, multi-centre phase II study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request patient information material
Condition
von Willebrand disease
Intervention
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.
Intervention type
Drug
Phase
Phase II
Drug names
Wilate®, Haemate® P
Primary outcome measure
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
01/09/2008
Overall trial end date
01/11/2008
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
6
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
01/09/2008
Recruitment end date
01/11/2008
Locations
Countries of recruitment
Bulgaria, Slovakia
Trial participating centre
Oberlaaerstrasse 235
Vienna
1100
Austria
Sponsor information
Organisation
Octapharma AG (Switzerland)
Sponsor details
Seidenstrasse 2
Lachen
8853
Switzerland
+41 (0)55 4512121
olaf.walter@octapharma.ch
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Octapharma AG (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list