Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

TerminadoFase 2ClinicalTrials.gov

ID: NCT00623727Tipo: INTERVENTIONALInicio: 1 de jun de 2008Fin estimado: 1 de oct de 2010

Traducción no disponible, mostrando original

Resumen

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 70 YearsSexo: MALE

Criterios de inclusión

Subjects with no history of FVIII inhibitor antibody formation
Males aged 12 to 70 years
Subjects with severe hemophilia A (\< 1% factor VIII \[FVIII\]:C)
Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
Subjects with no measurable inhibitor activity
Written informed consent by subject and parent / legal representative, if \< 18 years

Criterios de exclusión

Subjects who are receiving primary prophylaxis
Subjects on prophylaxis with documented requirements of \> 75 IU/kg/week
Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
Subjects with abnormal renal function
Subjects with elevated hepatic transaminases
Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
Subjects who require any pre-medication for FVIII injections

Intervenciones

biological

rFVIII-FS/pegylated liposomes (BAY79-4980)

35 IU/kg body weight intravenous 1x/week for 52 weeks This arm will be stopped by 30.04.10 the subjects will be offered to change to the active comparator arm

biological

rFVIII-FS/WFI (BAY14-2222)

25 IU/kg body weight intravenous 3x/week for 52 weeks

Ubicaciones

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBayer

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