Status:
TERMINATED
Optivate in People With Von Willebrand Disease Undergoing Surgery
Lead Sponsor:
Bio Products Laboratory
Conditions:
Von Willebrand Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.
Eligibility Criteria
Inclusion
- Have given written informed consent.
- Be aged 12 years or older.
- Have VWD of known type.
- Be due to undergo surgery, in which the investigator believes a VWF concentrate will be required.
- Have a known lack of, poor response to, or contraindication to, DDAVP, or require a type of surgery in which a plasma-derived product is appropriate.
- Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range.
- Female patients of child-bearing potential, with the exception of pregnant patients undergoing Caesarean surgery or other modes of delivery, including normal vaginal delivery, 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.
Exclusion
- Have a history of inhibitor development to VWF or FVIII or a positive result at screening (positive screen for VWF inhibitor; positive screen and a result of \>0.5 BU for FVIII inhibitor). A result at screening is not mandatory if the patient is to undergo emergency surgery and the local laboratory is unable to perform the analyses.
- Patients with thrombocytopenia (platelets \<50 x 109/L).
- Patients who have clinically significant renal disease (creatinine \>200 µmol/L).
- Patients who have clinically significant liver disease (ALT levels greater than three times the upper limit of the reference range).
- Presence of any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator.
- Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
- Have a recent history of alcohol or drug abuse.
- Administration of a new chemical entity within the 4 months preceding enrolment.
- Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment (screening visit) into this study, with the exception of the BPL clinical study Protocol 8VWF01.
- Female patients who are lactating.
- In the opinion of the investigator, the patient is unlikely to comply with the study protocol.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00404300
Start Date
February 1 2007
End Date
September 1 2008
Last Update
March 3 2010
Active Locations (4)
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1
Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
Haifa, Israel, 31096
2
Haddasah Ein-Karem Medical Center, P.O.Box 12000
Jerusalem, Israel, 91120
3
Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street
Petah Tikva, Israel, 49100
4
Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
London, United Kingdom, NW2 3QG