An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

CompletadoFase 3ClinicalTrials.gov

ID: NCT02137850Tipo: INTERVENTIONALInicio: 26 de jun de 2014Fin estimado: 7 de jun de 2023

Traducción no disponible, mostrando original

Resumen

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

Elegibilidad

Edad mínima: 0 YearsEdad máxima: 6 YearsSexo: MALE

Criterios de inclusión

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male, age below 6 years of age at the time of signing informed consent
Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results
No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable)

Criterios de exclusión

Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products
Previous participation in this trial. Participation is defined as first dose administered of trial product
Receipt of any investigational medicinal product within 30 days before screening
Congenital or acquired coagulation disorder other than haemophilia A
Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation

Intervenciones

drug

turoctocog alfa pegol

For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis

Ubicaciones

Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan

CABA, Argentina

Sanatorio Mayo Privado S.A

Córdoba, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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