- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243659
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
June 2, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Perth, Australia
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Vienna, Austria
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Budapest, Hungary
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Auckland, New Zealand
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Chirstchurch, New Zealand
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Warsawa, Poland
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Bucurest, Romania
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Malmö, Sweden
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Stockholm, Sweden
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California
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LaJolla, California, United States, 92093
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Michigan
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Detroit, Michigan, United States, 48201
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Detroit, Michigan, United States, 48202
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
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Pittsburg, Pennsylvania, United States, 15213
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Texas
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Houston, Texas, United States, 77030
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Virginia
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Charlottesville, Virginia, United States, 22908
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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Experimental: B
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Patients Who Achieved Hemostatic Efficacy After Surgery
Time Frame: 6 weeks
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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.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
October 20, 2005
First Submitted That Met QC Criteria
October 20, 2005
First Posted (Estimate)
October 24, 2005
Study Record Updates
Last Update Posted (Estimate)
June 3, 2011
Last Update Submitted That Met QC Criteria
June 2, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3082B2-311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemophilia A
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Christoph KönigsRoche Pharma AG; Chugai Pharma Germany GmbHRecruitingSevere Hemophilia A | Severe Hemophilia A With Inhibitor | Severe Hemophilia A Without InhibitorGermany
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GWT-TUD GmbHHannover Medical School; Hoffmann-La RocheCompleted
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Kathelijn FischerRadboud University Medical Center; University Medical Center Groningen; Maastricht... and other collaboratorsRecruitingAdolescent | Child | Hemophilia A With Inhibitor | Adult | Hemophilia A Without Inhibitor | Hemophilia A, SevereNetherlands
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Hoffmann-La RocheActive, not recruitingSevere Hemophilia A | Moderate Hemophilia ABrazil, Germany, Italy, Spain, United States, Turkey, United Kingdom, Tunisia, Canada, Hungary, Ireland, Morocco, Serbia
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Catalyst BiosciencesCompletedHemophilia A | Hemophilia B | Hemophilia A With Inhibitor | Hemophilia B With Inhibitor | Hemophilia A Without Inhibitor | Hemophilia B Without InhibitorBulgaria, Russian Federation
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JW PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A Without InhibitorKorea, Republic of
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PfizerCompletedFactor VIII Deficiency, Congenital | Hemophilia A, Congenital | Factor 8 Deficiency, Congenital | Autosomal Hemophilia A | Classic Hemophilia
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BioMarin PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A With Anti Factor VIIIUnited States, United Kingdom, Taiwan, Korea, Republic of, Brazil, Italy
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American Thrombosis and Hemostasis NetworkTakeda; CSL Behring; OctapharmaCompletedHemophilia A | Hemophilia B | Hemophilia | Hemophilia A With Inhibitor | Haemophilia | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
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BayerCompletedHemophilia A; Hemophilia BIsrael
Clinical Trials on ReFacto AF
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Wyeth is now a wholly owned subsidiary of PfizerCompleted
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PfizerTerminatedHemophilia ANetherlands, Spain, Greece, Italy, France, Belgium, Germany, Austria, Sweden, Hungary, Finland, United Kingdom, Denmark, Romania
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PfizerCompletedHemophilia ASpain, Finland, Serbia, Georgia, Italy, Romania, Sweden, Turkey, Ukraine
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Wyeth is now a wholly owned subsidiary of PfizerCompletedHemophilia A
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PfizerWithdrawn
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PfizerCompletedHemophilia ASpain, France, Turkey, Netherlands, Germany, Italy, Ukraine
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Wyeth is now a wholly owned subsidiary of PfizerCompletedHemophilia APoland, Belgium, France, Italy, Spain, United States, Australia, Netherlands, New Zealand, Sweden, Germany, Finland, Hungary
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Yale UniversityNational Institute on Drug Abuse (NIDA)CompletedDrug Use Disorders | Psychiatric Diagnosis | Diagnosis, Dual (Psychiatry)United States
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Neil SulkeSuspended