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

NCT ID: NCT04584892

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-12

Study Completion Date

2023-03-27

Brief Summary

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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.

Detailed Description

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Conditions

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Haemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Haemophilia A

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

Turoctocog alfa

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure 1452

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Milan, MI, Italy

Site Status

Novo Nordisk Investigational Site

Bologna, , Italy

Site Status

Novo Nordisk Investigational Site

Castelfranco Veneto, , Italy

Site Status

Novo Nordisk Investigational Site

Catania, , Italy

Site Status

Novo Nordisk Investigational Site

Cesena, , Italy

Site Status

Novo Nordisk Investigational Site

Florence, , Italy

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Napoli, , Italy

Site Status

Novo Nordisk Investigational Site

Roma, , Italy

Site Status

Novo Nordisk Investigational Site

Vicenza, , Italy

Site Status

Countries

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Italy

Other Identifiers

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U1111-1247-5494

Identifier Type: OTHER

Identifier Source: secondary_id

NN7008-4655

Identifier Type: -

Identifier Source: org_study_id