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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00853086
Other study ID # F7HAEM-3537
Secondary ID U1111-1130-5940
Status Completed
Phase N/A
First received February 27, 2009
Last updated November 15, 2016
Start date January 2008
Est. completion date June 2011

Study information

Verified date November 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Not required for observational study
Study type Observational

Clinical Trial Summary

This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.


Description:

Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- All haemophilia A or B patients with inhibitors treated with NovoSeven are included

Exclusion Criteria:

- No exclusion criteria beyond the contraindications described in the approved product information text

Study Design

Observational Model: Cohort


Intervention

Drug:
activated recombinant human factor VII
Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice

Locations

Country Name City State
United Kingdom Novo Nordisk Investigational Site Crawley

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes. Assessments at 6 month intervals Yes
See also
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