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Trial record 1 of 1 for:    NCT00243659
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Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

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ClinicalTrials.gov Identifier: NCT00243659
Recruitment Status : Completed
First Posted : October 24, 2005
Results First Posted : July 20, 2009
Last Update Posted : June 3, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 20, 2005
First Posted Date  ICMJE October 24, 2005
Results First Submitted Date  ICMJE May 29, 2009
Results First Posted Date  ICMJE July 20, 2009
Last Update Posted Date June 3, 2011
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Number of Patients Who Achieved Hemostatic Efficacy After Surgery [ Time Frame: 6 weeks ]
Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2005)
  • Assessment of hemostatic efficacy at the end of surgery
  • as determined by the investigator and/or the surgeon using the 4 point ordinal scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge [ Time Frame: 6 weeks ]
Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2005)
  • Efficacy endpoints:
  • · Assessment of hemostatic efficacy by the investigator at the day of
  • discharge from the hospital;
  • · Capture Total Consumption of ReFacto AF and Consumption per bleeding
  • event;
  • · Capture the number of bleeding episodes and response to treatment;
  • · Assess the pharmacokinetics of ReFacto AF in the patient population;
  • · Assess the incidence of less than expected therapeutic effect;
  • · Comparison of the predicted and actual estimated blood loss and
  • transfusion requirements;
  • · Monitor the types of continuous infusion regimens and comparison of
  • planned regimens versus regimens actually used;
  • · Assess patient compliance with prescribed outpatient;
  • Safety endpoints:
  • · Adverse events;
  • · Incidence of Factor VIII inhibitor development, thrombosis and
  • allergic reactions in the patient population
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
  • Experimental: A
    Intervention: Biological: ReFacto AF
  • Experimental: B
    Intervention: Biological: ReFacto AF
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
 (submitted: May 29, 2009)
30
Original Enrollment  ICMJE
 (submitted: October 20, 2005)
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
  • Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
  • Previously treated with at least 150 exposure days to any Factor VIII product
  • Normal hepatic and renal function tests and no other bleeding disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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