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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:
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EUCTR |
Last refreshed on:
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13 March 2017 |
Main ID: |
EUCTR2008-001910-25-SK |
Date of registration:
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13/05/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study
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Scientific title:
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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:
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17/07/2008 |
Target sample size:
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6 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001910-25 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Slovakia
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Inherited von Willebrand Disease (VWD) type 3 MedDRA version: 9.1
Level: LLT
Classification code 10047715
Term: Von Willebrand's disease
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Intervention(s)
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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-
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Primary Outcome(s)
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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.
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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.
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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.
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Source(s) of Monetary Support
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Results
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Results available:
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