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

Haemophilia A Clinical Trial

— THIRd  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584892
• Other study ID #: NN7008-4655
• Secondary ID: U1111-1247-5494
• Status: Completed
• Start date: April 12, 2021
• Est. completion date: March 27, 2023

Study information

• Verified date: November 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Haemophilia A
• Hemophilia A

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
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	Firenze
Italy	Novo Nordisk Investigational Site	Milano
Italy	Novo Nordisk Investigational Site	Milano	MI
Italy	Novo Nordisk Investigational Site	Napoli
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)	Count	Baseline (week 0)
Secondary	Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW	Count	Final visit (12 months)
Secondary	Change of PPX regimen: YES/NO	Count (participants who have changed regimen or not)	12 months after treatment initiation
Secondary	Reported reasons for change of PPX regimens	Count (reasons according to the predefined list, see below); Individual reported reasons for switch will be selected among the following predefined: to improve articular protection; due to bleedings; due to patients' needs, including: physical inactivity, work, recreational activity, travel, other.	Final visit (12 months)
Secondary	Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire	Points; The following sections of the BHERO questionnaire will be used: Haemophilia Activities List (HAL: measures the impact of haemophilia on self-perceived functional abilities in patients (42 questions in 7 domains). Scores from 1 (worst) to 6 (best). The final score is the sum of all the scores.); Recreational and sport activities; Brief pain inventory, exploring the presence and intensity of physical pain, and its impact on performance of daily activities.; International Physical Activities questionnaire (IPAQ) score (Score<700 = Inactive Patient, Score 700 to 2519 = Sufficiently active patient, Score = 2520 = Active or very active patient.	Final visit (12 months) vs Baseline (week 0)
Secondary	Difference in circulating turoctocog alfa levels	IU/mL; Before 12 months visit, monitoring will be reported only if measured in clinical practice due to bleedings or other clinical reasons.	Final visit (12 months) vs Baseline (week 0)
Secondary	Individual Annual Bleeding Rate (ABR)	Count	From baseline to final visit (12 months)