An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

CompletadoFase 3ClinicalTrials.gov

ID: NCT02141074Tipo: INTERVENTIONALInicio: 2 de jul de 2014Fin estimado: 27 de oct de 2022

Traducción no disponible, mostrando original

Resumen

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

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 at the time of signing informed consent
Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity level below or equal to 2%) based on medical records or central laboratory results
Previously untreated or exposed to FIX containing products less than or equal to 3 exposure days (5 previous exposures to blood components is acceptable)

Criterios de exclusión

Any history of FIX inhibitors (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 B
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)/LAR(s) (legally acceptable representative) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation

Intervenciones

drug

nonacog beta pegol

For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.

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.

An Open-label Single-arm Multicentre Non-controlled Phase... | EligiMed