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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01579968

Enrollment

Registered

2012-04-18

Start date

1999-03-10

Completion date

2010-03-09

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Brief summary

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.

Interventions

DRUGeptacog alfa (activated)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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®)

Design outcomes

Primary

Measure	Time frame
Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed	Year 1

Secondary

Measure	Time frame
Number of adverse events (AEs), including serious adverse events (SAEs)	Year 1, Year 10

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026