Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice

Novo Nordisk A/S321 enrolled

Overview

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal clinical practice conditions.

Study Type

OBSERVATIONAL

Enrollment

321

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Interventions

eptacog alfa (activated)DRUG

Prescription of eptacog alpha at the discretion of the physician

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment Exclusion Criteria: * Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective

Time frame: Year 1

Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective

Time frame: Year 10

Secondary Outcomes

Number of adverse events (AEs), including serious adverse events (SAEs)

Time frame: Baseline, every 1 year, Year 10

Data from ClinicalTrials.gov

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