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Main
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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00387192 |
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Date of registration:
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11/10/2006 |
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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 With OPTIVATE® in People With Von Willebrand Disease
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Scientific title:
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An Open Multi-centre Study in Patients With Von Willebrand Disease to Investigate the Pharmacokinetics, Efficacy and Safety of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and Von Willebrand Factor Concentrate |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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26 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00387192 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Israel
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United Kingdom
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Contacts
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Name:
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Charles Hay, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Manchester Haemophilia Comprehensive Care Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Have given written informed consent.
2. Be aged 12 years or older.
3. Have severe VWD (VWF:RCo <20%) of known type. Severity will be confirmed by a
current VWF:RCo result of <20%.
4. Be known or expected to require a concentrate for management of VWD.
5. Must have had at least one bleed in the last 12 months which required treatment with
a FVIII and VWF concentrate.
6. Have a known lack of, or poor response to, DDAVP.
7. Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the
reference range.
8. At the Baseline Visit (Visit 1), patients must have had at least 5 days since their
last infusion of replacement factor concentrate or DDAVP.
9. Female patients of child-bearing potential must have a negative result on a human
chorionic gonadotropin-based pregnancy test. If a female patient is or becomes
sexually active, she must practice contraception by using a method of proven
reliability for the duration of the study. Female patients must not be lactating.
Exclusion Criteria:
1. Have a history of inhibitor development to VWF or FVIII or a positive result at
screening.
2. Actively bleeding (Note: the patient can enter the study once the bleed is
controlled).
3. Presence of major systemic illnesses: renal disease, liver disease, or neurological
or psychiatric disease which would compromise the outcome of the study in the opinion
of the investigator.
4. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its
excipients.
5. Have a recent history of alcohol or drug abuse.
6. Administration of a new chemical entity within the 4 months preceding enrolment.
7. Participation in any other clinical study in which investigational or marketed drugs
were employed in the 30 days preceding enrolment into this study, with the exception
of the BPL clinical study Protocol 8VWF03.
8. In the opinion of the investigator, the patient is unlikely to comply with the study
protocol.
Age minimum:
12 Years
Age maximum:
N/A
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: Optivate
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Primary Outcome(s)
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Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall.
[Time Frame: Baseline vist]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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