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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring BLA Summary Report - Wilate, December 13, 2007

 

DATEDecember 13, 2007
FROMSolomon Yimam, Bioresearch Monitoring Branch, HFM-664
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
SUBJECTBioresearch Monitoring BLA Summary Report
SPONSOROctapharma AG
Seidenstrasse 2
CH-8852 Lachen, Switzerland
PRODUCTWILATE is a human plasma-derived, stable, high purity, double virus inactivated concentrate of freeze-dried FVIII and VWF. It is prepared using cryoprecipitate harvested from plasma collected in the U.S.  WILATE is supplied as a powder for reconstitution and intravenous injection.
THROUGHPatricia Holobaugh
Bioresearch Monitoring Branch Chief, HFM 664
TOTimothy Lee, HFM-392
Chair, BLA/STN 125251

FINAL SUMMARY STATEMENT

Results of three bioresearch monitoring inspections of three clinical sites did not reveal problems that impact the data submitted in the application.

 

BACKGROUND

Inspections of three clinical investigators were performed in support of this Biologics License Application (BLA).  Information from the BLA was compared to source documents during the inspections. The inspections focused on specific questions concerning the study.

 

STUDY TITLE:        A Prospective, Randomized, Controlled, Open-labeled, Two-arm Crossover Study Investigating the Pharmacokinetic Properties of WILATE and Humate-P® in Subjects with Inherited von Willebrand Disease (WIL-12).

The clinical investigator inspections assigned included the following:

Clinical InvestigatorStudy SiteLocationFDA 483Final Classification
Jerry S. Powell, MDUniversity of California at Davis
Hemophilia Treatment Center
Sacramento, CaliforniaYesNAI
Arthur R. Thompson, MD, PhDPuget Sound Blood CenterSeattle, WashingtonNONAI
Jorge DiPaolo, MDUniversity of Iowa
Hospitals & Clinics
Department of Pediatrics
 
Iowa City, IowaNONAI

INSPECTIONAL FINDINGS

The inspections of the three clinical investigators did not reveal any significant protocol deviations.

BIMO ADMINISTRATIVE FOLLOW-UP

Close out letters were issued to Dr. Jerry S. Powell,  Dr. Arthur R. Thompson, and Dr. Jorge DiPaolo.

Should you have any questions or comments about the contents of this memorandum or any aspect of Bioresearch Monitoring, please contact me at (301) 827-1948.

______________________

Solomon Yimam

Consumer Safety Officer