Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

Novo Nordisk A/S35 enrolled

Overview

This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B

Interventions

activated recombinant human factor VIIDRUG

Prescription is done at the discretion of the prescribing physician as part of normal clinical routine

Eligibility

Sex: MALEMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with congenital haemophilia and inhibitors to factor VIII or IX * Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle Exclusion Criteria: * Known or suspected allergy to study product(s) or related products * Clinically relevant coagulation disorders other than congenital haemophilia A or B

Locations (5)

Unnamed facility

Algiers, Algeria

Unnamed facility

Casablanca, Morocco

Unnamed facility

Muscat, Oman

Unnamed facility

Riyadh, Saudi Arabia

Unnamed facility

Dubai, United Arab Emirates

Outcomes

Primary Outcomes

Number of bleeds managed at home

Time frame: Month 8

Number of treatments resulting in the control of bleeding episode

Time frame: within 9 hours after the first injection of study product

Number of treatments resulting in effective pain relief

Time frame: within 9 hours after the first injection of study product

Secondary Outcomes

Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home

Time frame: Month 8

Proportion of patients who used their entire treatment at home

Time frame: Month 8

Data from ClinicalTrials.gov

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