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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01586936
Other study ID # F7-1949
Secondary ID
Status Completed
Phase N/A
First received April 11, 2012
Last updated February 23, 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 registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.


Recruitment information / eligibility

Status Completed
Enrollment 9
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:

- Treated with eptacog alpha (NovoSeven®)

Exclusion Criteria:

- Investigator decision to measure for antibody as unnecessary medical testing

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 Antibody production against eptacog alpha Up to 10 years
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