Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
NCT00884390
ABOUT THIS STUDY
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- Male patients greater than or equal to 12 years of age with severe hemophilia A (FVIII:C less than 1%).
- Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII replacement products.
- Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
- Serum albumin greater than or equal to the lower limit of normal (LLN).
- Platelet count greater than or equal to 100,000/µL.
- Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized ratio (INR) less than or equal to 1.5.
- HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load less than 200 particles/µL.
- Presence of any bleeding disorder in addition to hemophilia A.
- A positive FVIII inhibitor, according to the local laboratory, at screening; or any
Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the
testing laboratory.
- Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI])
during the screening period.
- Prior exposure to moroctocog alfa (AF-CC).
- Known hypersensitivity to hamster protein.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings | |||
Official Title ICMJE | A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings | |||
Brief Summary | The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products. | |||
Detailed Description | The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hemophilia A | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: ReFacto AF
Interventions:
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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 | Terminated | |||
Actual Enrollment ICMJE | 208 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | March 2013 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
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 | Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Romania, Spain, Sweden, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00884390 | |||
Other Study ID Numbers ICMJE | 3082B2-4432 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | August 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |