Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Post-marketing Observation Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human,) Alphanate(R), in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 Von Willebrand Disease|
- 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 (mostly major surgeries). [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- To assess the Day 0 (surgery day) and Day 1 (post-surgery day) treatment outcomes of each surgical procedure, rated by the investigator using a 2-point verbal rating scale. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Assessment of Safety and Tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|No Intervention: Alphanate SD/HT||
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.
Other Name: Alphanate(R) Factor VIII/VWF concentrate (Human).
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.
|Contact: Paul J Pinciaro, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Medical Center||Not yet recruiting|
|Cincinnati, Ohio, United States, 45229-3039|
|Contact: Ann Pillow 513-636-7198 email@example.com|
|United States, Oklahoma|
|Oklahoma Center for Bleeding and Clotting Disorders||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Sarah M Hawk, P.A. C 405-271-3661 ext 1 firstname.lastname@example.org|
|Study Director:||Paul J Pinciaro, PhD||Grifols Biologicals Inc.|