Study To Compare On-Demand Treatment To A Prophylaxis

Study To Compare On-Demand Treatment To A Prophylaxis

Study To Compare On-Demand Treatment To A Prophylaxis
Regimen Of BeneFIX In Subjects With Moderately Severe to Severe
Hemophilia B
Status: Completed
Study Phase: Phase 3
Start Date: September 2011 | Completion Date: April 2014
Condition(s): Hemophilia B
Full Title of Study
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%)
Overview
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.
Study Details
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy
Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary
Purpose: Treatment
Investigator Details
Lead Sponsor: Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Trial Location Details
Facility: UMBAL Sveti Georgi, Klinika po hematologia Plovdiv, Bulgaria
Facility: The Ottawa Hospital Ottawa, Canada
Facility: University Hospital Center Zagreb Zagreb, Croatia
Facility: Eulji University Hospital Daejeon, Korea, Republic of
Facility: Hospital Tengku Ampuan Afzan Kuantan, Malaysia
Facility: National Blood Centre Kuala Lumpur, Malaysia
Facility: Hospital y Clinica OCA Monterrey, Mexico
Facility: Instituto Biomedico de Investigacion A.C. Aguascalientes, Mexico
Facility: Nzoz Triclinium Warszawa, Poland
Facility: Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku Wroclaw, Poland
Facility: Singapore General Hospital Singapore, Singapore
Facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim
Dali Hematoloji Bilim Dali Fatih, Turkey
Facility: Hacettepe Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
Hematoloji Bolumu Ankara, Turkey
Facility: Ege Universitesi Tip Fakultesi Bornova/Izmir, Turkey
Facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Arastirma ve Uygulama
Hastanesi Hematoloji Poliklinigi Gaziantep, Turkey
Facility: Erciyes Universitesi Tip Fakultesi Hastaneleri M. Kemal Dedeman
Onkoloji Hastanesi KAYSER?, Erciyes, Turkey
Facility: Erciyes Universitesi Tip Fakultesi Kayseri, Turkey
Interventions
Biological: Nonacog alfa
Period 1: During on-demand period, dosing at the discretion of investigator.
Biological: Nonacog alfa
Period 2: During the prophylaxis period, 100 IU/kg once weekly
Information Source
ID Number: B1821010
NCT Identifier: NCT01335061
Health Authority: United States: Food and Drug Administration
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01335061
ClinicalTrials.gov processed this data on October 12, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
by this site. Please see the full source link above for retrieving further details from the government database.