- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037544
Study Evaluating ReFacto AF in Severe Hemophilia A
April 18, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.
Study Overview
Study Type
Interventional
Phase
- Phase 3
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
All
Description
Inclusion Criteria:
- Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
- Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
- Age greater than or equal to 12 years
- History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
- Adequate laboratory results
Exclusion Criteria:
- Presence of any bleeding disorder in addition to hemophilia A
- Concomitant therapy with immunosuppressive drugs
- Current or historical Factor VIII inhibitor
- Treatment with any investigational drug or device within the past 30 days
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
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
Primary Completion (Actual)
August 1, 2004
Study Completion (Actual)
August 1, 2004
Study Registration Dates
First Submitted
May 17, 2002
First Submitted That Met QC Criteria
May 17, 2002
First Posted (Estimate)
May 20, 2002
Study Record Updates
Last Update Posted (Estimate)
April 22, 2008
Last Update Submitted That Met QC Criteria
April 18, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3082B1-306
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, 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 PfizerCompletedHemophilia AUnited States, New Zealand, Australia, Hungary, Sweden, Austria, Poland, Romania
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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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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