Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (THIRd)

Novo Nordisk

Status: Completed

Conditions: Haemophilia A

Treatments: Drug: Turoctocog alfa

Study type: Observational

Funder types: Industry

Identifiers

NCT04584892

U1111-1247-5494 (Other Identifier)

NN7008-4655

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

18 participants in 1 patient group

Haemophilia A

Description:

Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy.

Treatment:

Drug: Turoctocog alfa