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Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients

Von Willebrand Disease Clinical Trial

Official title:
A Post-marketing Observational Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human), Alphanate®, in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 Von Willebrand Disease

Clinical Trial Summary

To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.

Clinical Trial Description

For the treatment of surgical procedures the intended dose of Alphanate® will be given as a single dose or as multiple doses over several days, depending on the clinical situation, and according to the Full Prescribing Information guideline and the investigator's judgment. For each treated event, the subject's treatment period will be finished when, in the opinion of the local Investigator, the participating subject would not benefit from further infusions of the study concentrate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00555555
Study type Interventional
Source Grifols Biologicals, LLC
Contact
Status Active, not recruiting
Phase Phase 4
Start date September 2007
Completion date March 2029
View Details
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