A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors

CompletadoFase 2ClinicalTrials.gov

ID: NCT00486278Tipo: INTERVENTIONALInicio: 1 de jun de 2007Fin estimado: 1 de jun de 2010

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Elegibilidad

Edad mínima: 12 YearsSexo: MALE

Criterios de inclusión

years of age or older (at least 18 years in Croatia, France and United Kingdom (UK))
Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry

Criterios de exclusión

Known allergy to rFVIIa, and/or suspected allergy to trial product
Platelet count lower than 50,000 mm\^3 based on medical records at trial entry (visit 1)
Any clinical signs or history of thromboembolic events
Advanced atherosclerotic disease
Severe liver disease based on medical records within the past 12 months at trial entry (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit of normal reference range
Known active pseudo tumours (documented bleeding requiring treatment within the last 3 months
Subject had any (major) surgical procedure in the 30 days prior to screening into the trial. a. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject

Intervenciones

drug

eptacog alfa (activated)

90 mcg/kg, injected i.v.

drug

vatreptacog alfa (activated)

5 mcg/kg, injected i.v.

drug

vatreptacog alfa (activated)

10 mcg/kg, injected i.v.

drug

vatreptacog alfa (activated)

20 mcg/kg, injected i.v.

drug

vatreptacog alfa (activated)

40 mcg/kg, injected i.v.

drug

vatreptacog alfa (activated)

80 mcg/kg, injected i.v.

Ubicaciones

Novo Nordisk Investigational Site

Ciudad Autónoma de Bs. As., Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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