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Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities | Clinical Trials | Clareo Health

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

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

NCT04584892•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

Locations (10)

Novo Nordisk Investigational Site

Milan, MI, Italy

Novo Nordisk Investigational Site

Bologna, Italy

Novo Nordisk Investigational Site

Castelfranco Veneto, Italy

Novo Nordisk Investigational Site

Catania, Italy

Novo Nordisk Investigational Site

Cesena, Italy

Novo Nordisk Investigational Site

Florence, Italy

Novo Nordisk Investigational Site

Milan, Italy

Novo Nordisk Investigational Site

Naples, Italy

Novo Nordisk Investigational Site

Roma, Italy

Novo Nordisk Investigational Site

Vicenza, Italy

Key Dates

Start Date

April 12, 2021

Primary Completion Date

March 27, 2023

Completion Date

March 27, 2023

Last Updated

November 28, 2023

Enrollment

18

ACTUAL participants

Conditions

Haemophilia A

Interventions

Turoctocog alfa

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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