Brief Title
Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities
Official Title
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
Brief Summary
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.
Study Type
Observational
Primary Outcome
Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)
Secondary Outcome
Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW
Condition
Haemophilia A
Intervention
Turoctocog alfa
Study Arms / Comparison Groups
Haemophilia A
Description: Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
75
Start Date
February 28, 2021
Completion Date
August 31, 2022
Primary Completion Date
August 31, 2022
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.
Gender
All
Ages
12 Years - N/A
Contacts
Clinical Reporting Anchor and Disclosure 1452, (+1) 866-867-7178, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04584892
Organization ID
NN7008-4655
Secondary IDs
U1111-1247-5494
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Clinical Reporting Anchor and Disclosure 1452, Study Director, Novo Nordisk A/S
Verification Date
February 2021