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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00694785 |
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Date of registration:
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06/06/2008 |
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Primary sponsor: |
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Public title:
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A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B
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Scientific title:
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A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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2 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00694785 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female patients;
- = 16 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:RCo), Factor VIII (FVIII) activity,
ristocetin-induced platelet aggregation (RIPA), platelet function analyzer (PFA-100®)
closure time, bleeding time (BT), VWF multimer test, VWF: platelet-binding (VWF:PB)
activity, etc.)
- Thrombocytopenia (defined as a platelet count < 100 per nL on at least 2 occasions
within the month 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.
Exclusion Criteria:
- Patients with a possible co-existing or alternative hematologic diagnosis which can
account for the laboratory findings of thrombocytopenia, etc.;
- Any significant medical co-morbidity which would pose an increased risk of bleeding
(e.g., recent trauma or surgery, a history of gastrointestinal ulcers, etc.) or
thrombosis (e.g., history of recurrent deep vein thrombosis (DVT).
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Von Willebrand Disease
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Intervention(s)
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Drug: ARC1779
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Primary Outcome(s)
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To evaluate the effect of ARC1779 Injection on platelet counts in vWD-2B patients who have thrombocytopenia at baseline.
[Time Frame: 10 days]
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Secondary Outcome(s)
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To assess the concentration-response relationships among ARC1779 pharmacokinetic (PK) and pharmacodynamic (PD) parameters
[Time Frame: 10 days]
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Secondary ID(s)
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ARC1779-010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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