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Completed

NCT Number: NCT06574984

Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients

The study has descriptive purposes, with aim of assessing how turoctocog alfa is used in the everyday practice and to provide a baseline for the management of haemophilia A and does not involve any change in the clinical management of participants. Data will be extrapolated from the existing paper based medical records and uploaded to an electronic database specifically created for the study. Baseline information/history will be recorded at time of switching from previous FVIII replacement therapy to turoctocog alfa from the enrolled participants and outcomes will be collected according to participants visit format.

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Key information

Conditions

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

Sex eligibility

Male

Study type

Observational

Primary location

National centre for Hamophilia, Baghdad, Iraq

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Paediatric and adult male patients
  • On-demand and prophylactic patients with haemophilia A (any severity)
  • Only previously treated patients (previous FVIII replacement therapy) will be included in the study

Exclusion criteria

  • Patients diagnosed with coagulation disorders other than haemophilia A such as Von Willebrand disease
  • Patients with documented presence of any FVIII inhibitor

Treatment and study plan

turoctocog alfa

Drug

Turoctocog alfa was administered intravenously.

Other names: NovoEight

Primary outcomes

  1. Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy

    Time frame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa

    Measured as count of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12.

Secondary outcomes

  1. ABRs among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy

    Time frame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa

    Measured as number of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12 across 4 age segments ( less than [<] 8 years, 8-14 years, 15-18 years, greater than [>] 18 years).

  2. Change of primary prophylaxis regimen

    Time frame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa

    Measured as Yes/No.

  3. Dose of turoctocog alfa

    Time frame: At month 12 after switching to turoctocog alfa

    Measured as international uniit per kilogram (IU/kg).

  4. Haemostatic response to turoctocog alfa

    Time frame: At baseline and at month 12

    Measured as excellent, good, moderate, none.

  5. Spontaneous ABR

    Time frame: At month 12 after switching to turoctocog alfa

    Measured as number of reported spontaneous bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12.

  6. Annualized joint bleed rate (AJBR)

    Time frame: At month 12 after switching to turoctocog alfa

    Measured as number of reported joint bleeding episodes divided by the observation period in months multiplied by 12.

  7. New target joint

    Time frame: At month 12 after switching to turoctocog alfa

    Measured as number resolution (Yes/No) affected joints.

  8. Severity of bleeding

    Time frame: At month 12 after switching to turoctocog alfa

    Measured as mild / moderate / severe.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Descriptive Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients - An Observational Retrospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Jun 17, 2026

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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