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Sponsored by: |
Bio Products Laboratory |
Information provided by: | Bio Products Laboratory |
ClinicalTrials.gov Identifier: | NCT00404300 |
An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.
Condition | Intervention | Phase |
Von Willebrand Disease |
Drug: Optivate |
Phase III |
Genetics Home Reference related topics: | hemophilia von Willebrand disease |
ChemIDplus related topics: | Factor VIII Octocog alfa |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Multi-Centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and Von Willebrand Factor Concentrate, in Patients With Von Willebrand Disease Who Are Undergoing Surgery |
Estimated Enrollment: | 25 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2008 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven Morley | +44(0) 1423 816594 | morley.steve@kendle.com |
Israel | |||||
Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street | Recruiting | ||||
Petah Tikva, Israel, 49100 | |||||
Contact: Aida Inbal, Prof | |||||
Rambam Health Care Campus, 8 Haaliya St., Bat-Galim | Recruiting | ||||
Haifa, Israel, 31096 | |||||
Contact: Benjamin Brenner, Prof | |||||
Haddasah Ein-Karem Medical Center, P.O.Box 12000 | Recruiting | ||||
Jerusalem, Israel, 91120 | |||||
Contact: David Varon, Prof | |||||
United Kingdom | |||||
Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital | Recruiting | ||||
London, United Kingdom, NW2 3QG |
Bio Products Laboratory |
Principal Investigator: | Thynn Thynn Yee | Royal Free Hospital |
Sponsor's homepage 
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Study ID Numbers: | 8VWF03 |
First Received: | November 27, 2006 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00404300 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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