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

Novo Nordisk A/S139 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

139

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B

Interventions

activated recombinant human factor VIIDRUG

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

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Crawley, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Assessments at 6 month intervals

Data from ClinicalTrials.gov

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