Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database

United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00853086

Enrollment

139

Registered

2009-03-02

Start date

2008-01-31

Completion date

2011-06-30

Last updated

2016-11-16

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, Haemophilia B

Brief 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.

Detailed description

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

Interventions

DRUGactivated recombinant human factor VII

Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice

Study design

Observational model

COHORT

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* No

Design outcomes

Primary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

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