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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Apr 2021

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

October 6, 2020

Completed

8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2023

Completed

Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

October 6, 2020

Last Update Submit

November 27, 2023

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

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 Outcomes (6)

Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW
Final visit (12 months)
Change of PPX regimen: YES/NO
12 months after treatment initiation
Reported reasons for change of PPX regimens
Final visit (12 months)
Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire
Final visit (12 months) vs Baseline (week 0)
Difference in circulating turoctocog alfa levels
Final visit (12 months) vs Baseline (week 0)
+1 more secondary outcomes

Study Arms (1)

Haemophilia A

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

Drug: Turoctocog alfa

Interventions

Turoctocog alfaDRUG

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.

Haemophilia A

Eligibility Criteria

Age12 Years+

Sexall

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.