Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
NCT01335061
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- Documented history of moderately-severe to severe hemophilia B (FIX activity =2%).
- Male subjects, aged 12 years to 65 years.
- Subjects with at least 100 exposure days (EDs) to factor IX products.
- Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12-month period before the Screening visit.
- Subjects who have received FIX as a primary or secondary prophylaxis regimen within
the last 12 months prior to the Screening visit.
- Subjects who have had major surgery or an orthopedic surgical procedure within the
past 3 months prior to Screening visit.
- Subjects for which major surgery or orthopedic surgery is planned within the duration
of study participation.
- Subjects with a past history of, or current FIX inhibitor, defined as >ULN (upper
limit of normal) of the reporting laboratory.
- Subjects with a known hypersensitivity to any FIX product or hamster protein.
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Descriptive Information | ||||
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Brief Title ICMJE | Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B | |||
Official Title ICMJE | A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%) | |||
Brief Summary | The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hemophilia B | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | BeneFIX
Interventions:
| |||
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 | 25 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Actual Study Completion Date ICMJE | April 2014 | |||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 12 Years to 65 Years (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 | Bulgaria, Canada, Croatia, Korea, Republic of, Malaysia, Mexico, Poland, Singapore, Turkey | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01335061 | |||
Other Study ID Numbers ICMJE | B1821010 3090A1-3306 ( Other Identifier: Alias Study Number ) 2011-000520-15 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
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 | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |