Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
NCT ID: NCT00851721
Last Updated: 2021-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
52 participants
INTERVENTIONAL
2009-03-31
2012-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prophylaxis arm
Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)
85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
On-demand arm
Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)
FEIBA NF dose and dosing interval as prescribed by the treating physician
Interventions
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Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)
85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)
FEIBA NF dose and dosing interval as prescribed by the treating physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The participant is ≥ 4 to ≤ 65 years of age
* The participant has a Karnofsky performance score of ≥ 60
* Hemophilia A and B of any severity, with documented history of high-titer inhibitor (\> 5 Bethesda unit (BU)) for at least 12 months; or, if inhibitor titer is ≤ 5 BU, and the participant is refractory with increased dosing of either factor VIII (FVIII) or factor IX (FIX), as demonstrated from the participant's medical history
* Currently being treated on an on-demand basis for treatment of bleeding episodes
* Adequate venous access, with or without central venous device
* ≥ 12 bleeding episodes requiring treatment with by-passing agents in the past 12 months, based on medical history
* Competent in-home treatment and infusion therapy
* Currently using bypassing agents (activated prothrombin complex concentrate (APCC) or recombinant activated factor VII (rFVIIa)) for treatment of bleeding episodes
* HCV-, either by antibody testing or polymerase chain reaction (PCR); or HCV+ with stable hepatic disease
* HIV-, or HIV+ with stable disease and CD4 count \> 200 cells/mm3 at screening
* Female participant of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
Exclusion Criteria
* Currently on regular prophylactic therapy to prevent bleeding episodes
* Clinically symptomatic liver disease (e.g. diagnosis of cirrhosis \[confirmed by liver biopsy\], portal vein hypertension, ascites, prothrombin time (PT) 5 seconds above upper limit of normal)
* Platelet count \< 100,000/ml
* Planned elective surgery during participation in this study
* Participant is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry
* Planned use of pegylated or non-pegylated alpha-interferon with or without ribavirin for HCV infected participants or planned use of a protease inhibitor for HIV infected participants. Participants currently taking any of these medications for a 30-day course are eligible.
* Clinically significant increase in D-dimer levels from historical baseline and/or associated with chronic liver disease or clinically evident thromboembolic event
* Known hypersensitivity to anti-inhibitor coagulant complexes (AICCs)
* Currently treated with a systemic immunomodulating drug
* Prior history of thromboembolic event: acute myocardial infarction, deep vein thrombosis, or pulmonary embolism
* Diagnosis of advanced atherosclerosis, malignancy and/or other diseases that may increase the participant's risk of thromboembolic complications
* Clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance
4 Years
65 Years
ALL
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Chicago, Illinois, United States
Cleveland, Ohio, United States
Rio de Janeiro, Rio de Janeiro, Brazil
São Paulo, São Paulo, Brazil
Sofia, , Bulgaria
Zagreb, , Croatia
Kanagawa, , Japan
Nara, , Japan
Wellington, , New Zealand
Krakow, , Poland
Warsaw, , Poland
Bucharest, , Romania
Timișoara, , Romania
Kirov, , Russia
Moscow, , Russia
Yekaterinburg, , Russia
Lviv, , Ukraine
Countries
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References
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Antunes SV, Tangada S, Stasyshyn O, Mamonov V, Phillips J, Guzman-Becerra N, Grigorian A, Ewenstein B, Wong WY. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2014 Jan;20(1):65-72. doi: 10.1111/hae.12246. Epub 2013 Aug 1.
Other Identifiers
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2008-003855-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
090701
Identifier Type: -
Identifier Source: org_study_id
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