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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-008532-82-AT |
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Date of registration:
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21/01/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2B
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Scientific title:
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A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2B |
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Date of first enrolment:
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19/02/2009 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008532-82 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Male or female patients;
• =18 to = 75 years of age;
• Diagnosis of VWD-2B according to national expert guidelines for the USA [1] and Europe [2] based on medical history and findings from a matrix of laboratory assays which may include: platelet count, concentration of VWF antigen (VWF:Ag), VWF ristocetin cofactor activity (VWF:RiCo), Factor VIII (FVIII) activity, ristocetin-induced platelet aggregation (RIPA), platelet function analyzer (PFA-100®) closure time, cutaneous bleeding time (CBT), VWF multimer test, VWF: platelet-binding (VWF:PB) activity, etc.;
• Chronic thrombocytopenia, defined as a platelet count <100 per nL on at least 2 occasions within the 30 days preceding enrollment;
• Female patients of reproductive age must be enrolled within 1 to 7 days of the cessation of preceding menses;
• Female patients must be non-pregnant and willing to use effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment;
• Male patients must agree to use a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment;
• All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.
Are the trial subjects under 18? no
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:
• Patients with a possible co-existing or alternative hematologic diagnosis which can account for the laboratory findings of thrombocytopenia, etc.;
• Co-existing conditions which are associated with an increased risk of intraparenchymal bleeding, e.g. recent major trauma or surgery
• Pregnancy
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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von Willebrand Disease type 2B
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Intervention(s)
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Product Name: ARC1779
Product Code: ARC1779
Pharmaceutical Form: Solution for infusion
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Primary Outcome(s)
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Main Objective: To determine the effect of ARC1779 Injection infusion on platelet count in VWD-2B patients who have chronic thrombocytopenia;
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Primary end point(s): platelet counts
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Secondary Objective: To determine the effect of ARC1779 Injection infusion on von Willebrand Factor Antigen, Ristocetin Cofactor Activity, Factor VIII, Multimers, activated partial thromboplastin time, platelet aggregation, PFA-100 and other coagulation tests
To evaluate the safety and tolerability of ARC1779 Injection in VWD-2B patients.
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Secondary ID(s)
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ARC1779-010b
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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