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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 13 March 2017
Main ID:  EUCTR2008-001910-25-SK
Date of registration: 13/05/2008
Prospective Registration: Yes
Primary sponsor: Octapharma AG
Public title: Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study
Scientific title: Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study
Date of first enrolment: 17/07/2008
Target sample size: 6
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001910-25
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Slovakia
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
To qualify for enrolment, each subject must satisfy the following criteria before study entry:
1. Must have defined inherited VWD type 3.
2. Must be a 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. Be negative for HBsAg.
4. For HIV-positive subjects: must have
a baseline CD4+ cell count of >200/mm3, and a platelet count of >100,000/dL.
5. Freely give 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects will not be included if any of the following exclusion criteria are met:
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 VWF/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.

Before administration of one of the studied drugs, the following exclusion criteria must be checked and if any of these criteria are met the subject may not be treated at this point of time:
1. Subject in active bleeding state.
2. Administration of plasma, other plasma derivatives, blood products, cryoprecipitate, or DDAVP within 7 days before study drug injection.
3. Administration of acetylsalicylic acid or other NSAIDs within 7 days prior to study drug injection.

4. Before the 2nd study drug administration only (i.e. Visit 7):
4a) Previous study drug injection took place less than 7 days or
4b) more than 4 weeks ago.
If any of the criteria 4. – 4a) are met, the PK assessment has to be postponed, however, the subject may stay in the study. Subjects who meet criteria 4b) will be withdrawn from the study



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Inherited von Willebrand Disease (VWD) type 3
MedDRA version: 9.1 Level: LLT Classification code 10047715 Term: Von Willebrand's disease
Intervention(s)

Trade Name: WILATE® 450
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 400VWF/450FVIII-

Trade Name: Haemate® P 250
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: von Willebrand factor and coagulation factor VIII in combination
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 600VWF/250FVIII-

Primary Outcome(s)
Primary end point(s): The in-vivo half life (t½) of WILATE® is the primary endpoint and will be calculated for VWF:RCo, FVIII:C, VWF:Ag, and VWF:CB.
The calculations will be made by applying non-compartmental pharmacokinetic methods determined from plasma levels obtained at pre-defined time points.
Secondary Objective: To compare the pharmacokinetic profile (PK) of WILATE® with that of Haemate® P; To calculate the incremental recovery of VWF:RCo, FVIII:C, VWF:Ag, and VWF:CB; To assess the tolerability.
Main Objective: To determine the half-life of WILATE® in terms of the ristocetin cofactor activity (VWF:RCo), the FVIII coagulant activity (FVIII:C), the VWF antigen (VWF:Ag), and collagen binding activity (VWF:CB) of WILATE® and to compare these parameters with those for Haemate® P.
Secondary Outcome(s)
Secondary ID(s)
WIL-21
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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