Clinical trial

Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (THIRd). An Observational, Prospective, Multicentre, Cohort Study on Italian Patients With Haemophilia A in Prophylaxis Treatment With Turoctocog Alfa Under Current Clinical Conditions

Name

NN7008-4655

Description

This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.

Trial arms

Trial start

2021-04-12

Estimated PCD

2023-03-27

Trial end

2023-03-27

Status

Completed

Treatment

Turoctocog alfa

Patients will be treated with commercially available NovoEight® (turoctocog alfa) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available NovoEight® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Arms:

Haemophilia A

Size

Primary endpoint

Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)

Baseline (week 0)

Eligibility criteria

Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female, age above or equal to 12 years at the time of signing informed consent. * Haemophilia A (any severity), needing prophylactic therapy (with the usual recommended doses). * Decision to treat with turoctocog alfa, made by the treating Physician and the subject/Legally Acceptable Representative (LAR) based on local label before and independently from the decision to include the subject in this study. Exclusion Criteria: * Previous participation in this study, defined as previously signed informed consent; * Presence of other coagulation disorders; * Presence of any inhibitor; * Mental problems, poor compliance, linguistic barriers or other conditions which can impede the understanding of the study aims and the participation to it.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

Updated at

2023-11-28

1 organization

1 product

1 indication

Product

Turoctocog alfa

Indication

Hemophilia A

Organization

Novo Nordisk