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OpenTrials
Completed

NCT Number: NCT01579955

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®)

Treatment and study plan

eptacog alfa (activated)

Drug

Prescription of eptacog alpha at the discretion of the physician

Primary outcomes

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

    Time frame: Year 1

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

    Time frame: Year 10

Secondary outcomes

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

    Time frame: Baseline, every 1 year, Year 10

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
1999
Primary completion
2010
Study completion
2010
First posted
Apr 18, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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