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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01579955

Enrollment

321

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®) under normal clinical practice conditions.

Interventions

DRUGeptacog alfa (activated)

Prescription of eptacog alpha at the discretion of the physician

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

Exclusion criteria

* Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)

Design outcomes

Primary

Measure	Time frame
Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective	Year 1

Secondary

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

Countries

Japan

Outcome results

None listed

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