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Completed

NCT Number: NCT04584892

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

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.

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Key information

Conditions

Haemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Milan, MI, Italy

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

turoctocog alfa

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.

Primary outcomes

  1. Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)

    Time frame: Baseline (week 0)

    Count

Secondary outcomes

  1. Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW

    Time frame: Final visit (12 months)

    Count

  2. Change of PPX regimen: YES/NO

    Time frame: 12 months after treatment initiation

    Count (participants who have changed regimen or not)

  3. Reported reasons for change of PPX regimens

    Time frame: Final visit (12 months)

    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.

  4. Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire

    Time frame: Final visit (12 months) vs Baseline (week 0)

    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.

  5. Difference in circulating turoctocog alfa levels

    Time frame: Final visit (12 months) vs Baseline (week 0)

    IU/mL

    Before 12 months visit, monitoring will be reported only if measured in clinical practice due to bleedings or other clinical reasons.

  6. Individual Annual Bleeding Rate (ABR)

    Time frame: From baseline to final visit (12 months)

    Count

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: THIRd

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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