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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01579955
Other study ID # F7-1947
Secondary ID
Status Completed
Phase N/A
First received April 11, 2012
Last updated February 22, 2017
Start date March 10, 1999
Est. completion date March 9, 2010

Study information

Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 321
Est. completion date March 9, 2010
Est. primary completion date March 9, 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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®)

Study Design


Intervention

Drug:
eptacog alfa (activated)
Prescription of eptacog alpha at the discretion of the physician

Locations

Country Name City State
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective Year 1
Primary Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective Year 10
Secondary Number of adverse events (AEs), including serious adverse events (SAEs) Baseline, every 1 year, Year 10
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