NCT00555555

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Grifols Biologicals, LLC · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Von Willebrand Disease

Interventions

Type	Name	Description
BIOLOGICAL	Alphanate SD/HT	A general guideline based on the product Full Prescribing Information is recommended with a maximum dose of 80 VWF:RCof IU/kg. The number of administrations before, during, and after the surgery procedure depends on the subject's clinical condition and the type of surgery itself. Single administrations or multiple doses may be appropriate. The dose of Alphanate® administered to each subject will be recorded as IU of VWF:RCof and also as IU of FVIII:C. The lot number for each vial of concentrate administered will also be recorded.

Timeline

• Start date: 2007-09-01
• Primary completion: 2028-12-01
• Completion: 2029-03-01
• First posted: 2007-11-08
• Last updated: 2023-08-25