A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01233258Tipo: INTERVENTIONALInicio: 1 de ene de 2011Fin estimado: 1 de dic de 2012

Traducción no disponible, mostrando original

Resumen

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 65 YearsSexo: MALE

Criterios de inclusión

Male, aged 12 to 65 years
Severe hemophilia A
History of more than 150 exposure days (ED) with clotting factor concentrates
Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
No current Factor VIII inhibitor or history of inhibitor
Willing to use electronic patient diary

Criterios de exclusión

Presence of another bleeding disease that is different from hemophilia A
Thrombocytopenia
Abnormal renal function
Presence of active liver disease
Known hypersensitivity to FVIII

Intervenciones

biological

rFVIII (BAY81-8973) on demand

Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization

biological

rFVIII (BAY81-8973) prophylaxis low-dose

Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.

biological

rFVIII (BAY81-8973) prophylaxis high-dose

Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.

Ubicaciones

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Corrientes, Corrientes Province, Argentina

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBayer

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