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Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia B

Intervention: Nonacog alfa (Biological); Nonacog alfa (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: 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 Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Annualized Number of Bleeding Episodes.

Secondary outcome:

Response to On-Demand Treatment for All Bleeding Episodes.

Number of Nonacog Alfa, Recombinant Factor IX (BeneFIX) Infusions Used to Treat Each Bleeding Episode.

Number of Breakthrough (Spontaneous/Non-Traumatic) Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX.

Average Infusion Dose.

Total Factor Consumption.

Incidence of Less Than Expected Therapeutic Effect (LETE)


Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Male.


Inclusion Criteria:

- Documented history of moderately-severe to severe hemophilia B (FIX activity

- 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 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.

Locations and Contacts

UMBAL Sveti Georgi, Klinika po hematologia, Plovdiv 4002, Bulgaria

University Hospital Center Zagreb, Zagreb 10000, Croatia

Eulji University Hospital, Daejeon 302-799, Korea, Republic of

National Blood Centre, Kuala Lumpur 50400, Malaysia

Instituto Biomedico de Investigacion A.C., Aguascalientes 20127, Mexico

Nzoz Triclinium, Warszawa 02-797, Poland

Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku, Wroclaw 50-367, Poland

Singapore General Hospital, Singapore 169608, Singapore

Hacettepe Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bolumu, Ankara 06100, Turkey

Ege Universitesi Tip Fakultesi, Bornova/Izmir 35100, Turkey

Gaziantep Universitesi Tip Fakultesi Sahinbey Arastirma ve Uygulama Hastanesi Hematoloji Poliklinigi, Gaziantep 27300, Turkey

Erciyes Universitesi Tip Fakultesi Hastaneleri M. Kemal Dedeman Onkoloji Hastanesi, KAYSERÄ°, Erciyes 38039, Turkey

Erciyes Universitesi Tip Fakultesi, Kayseri 38039, Turkey

Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali, Fatih, Istanbul 34098, Turkey

Hospital y Clinica OCA, Monterrey, Nuevo Leon 64000, Mexico

The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada

Hospital Tengku Ampuan Afzan, Kuantan, Pahang 25200, Malaysia

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2011
Last updated: May 12, 2015

Page last updated: August 20, 2015

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