Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
NCT ID: NCT01335061
Last Updated: 2015-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2011-09-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BeneFIX
Nonacog alfa
Period 1: During on-demand period, dosing at the discretion of investigator.
Nonacog alfa
Period 2: During the prophylaxis period, 100 IU/kg once weekly
Interventions
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Nonacog alfa
Period 1: During on-demand period, dosing at the discretion of investigator.
Nonacog alfa
Period 2: During the prophylaxis period, 100 IU/kg once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
65 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UMBAL Sveti Georgi, Klinika po hematologia
Plovdiv, , Bulgaria
The Ottawa Hospital
Ottawa, Ontario, Canada
University Hospital Center Zagreb
Zagreb, , Croatia
National Blood Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Instituto Biomedico de Investigacion A.C.
Aguascalientes, Aguascalientes, Mexico
Hospital y Clinica OCA
Monterrey, Nuevo León, Mexico
Nzoz Triclinium
Warsaw, , Poland
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Wroclaw, , Poland
Singapore General Hospital
Singapore, , Singapore
Eulji University Hospital
Daejeon, , South Korea
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali
Fatih, Istanbul, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bolumu
Ankara, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Bornova/Izmir, , Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Sahinbey Arastirma ve Uygulama Hastanesi Hematoloji Poliklinigi
Gaziantep, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastaneleri M. Kemal Dedeman Onkoloji Hastanesi
Kayseri̇, Erciyes, , Turkey (Türkiye)
Countries
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References
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Wojciechowski J, Gaitonde P, Hughes JH, Ravva P. Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B. Clin Pharmacokinet. 2025 Oct;64(10):1531-1548. doi: 10.1007/s40262-025-01535-y. Epub 2025 Aug 1.
Tortella BJ, Carr ME, Rendo P, Korth-Bradley J, Smith LM, Kavakli K. Once-weekly prophylaxis regimen of nonacog alfa in patients with hemophilia B: an analysis of timing of bleeding event onset. Blood Coagul Fibrinolysis. 2021 Apr 1;32(3):180-185. doi: 10.1097/MBC.0000000000001012.
Related Links
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Other Identifiers
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3090A1-3306
Identifier Type: OTHER
Identifier Source: secondary_id
2011-000520-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1821010
Identifier Type: -
Identifier Source: org_study_id
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