Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
NCT00243659
Last updated date
ABOUT THIS STUDY
This study will examine the efficacy and safety of ReFacto AF in patients with severe and
moderately severe hemophilia A undergoing elective major surgery when administered by either
bolus injections (BI) or continuous infusion (CI).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Hemophilia A
Sex
Male
Age
12 + years
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Hemophilia AStudy Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
NCT00243659
- LaJolla, California
- Detroit, Michigan
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- Chapel Hill, North Carolina
- Hershey, Pennsylvania
- Pittsburg, Pennsylvania
- Houston, Texas
- Charlottesville, Virginia
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- Vienna,
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery | |||
Official Title ICMJE | An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery | |||
Brief Summary | This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hemophilia A | |||
Intervention ICMJE | Biological: ReFacto AF | |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 30 | |||
Original Enrollment ICMJE | 50 | |||
Actual Study Completion Date ICMJE | June 2008 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Hungary, New Zealand, Poland, Romania, Sweden, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00243659 | |||
Other Study ID Numbers ICMJE | 3082B2-311 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |