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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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2 October 2017 |
Main ID: |
EUCTR2006-000663-28-PL |
Date of registration:
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05/11/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public 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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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 |
Date of first enrolment:
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Target sample size:
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26 |
Recruitment status: |
NA |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000663-28 |
Study type:
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Interventional clinical trial of medicinal product |
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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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Poland
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United Kingdom
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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 spontaneous 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, or for whom DDAVP is contraindicated. 7. Have a prothombin 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 (see section 9.3.10 regarding the use of other concomitant medication). 9. Female patients of child-bearing potential must have a negatice 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. 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: 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, in such cases patients should have completed their End-of study visit either before or on the day of screening for this study. 8. In the option of the investigator, the pateint is unlikely to comply with the study protocol.
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 Willebrands Disease 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: Optivate Product Code: N/A Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Human coagulation factor VIII associated with von Willebrand factor (VWF) Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): AUC (0-t), AUC(0-72h), MRT(0-t) and MRT (0-72h) for VWF:RCo at the Baseline Visit (Visit 1) by VWD type and overall
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Secondary Objective: Efficacy and Safety of Optivate in long-term use over at least 12 months.
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Main Objective: Pharmacokinetics of Optivate
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Source(s) of Monetary Support
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Results
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Results available:
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