Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

Novo Nordisk A/S86 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®) when undergoing surgery under normal clinical practice conditions.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Interventions

eptacog alfa (activated)DRUG

Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery 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

Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed

Time frame: Year 1

Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed

Time frame: Year 10

Secondary Outcomes

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

Time frame: Year 1, Year 10

Data from ClinicalTrials.gov

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