Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients

February 11, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Baghdad, Iraq
        • Recruiting
        • Novo Nordisk Investigational Site
      • Baghdad, Iraq, 10001
        • Enrolling by invitation
        • National centre for Hamophilia
      • Basra, Iraq, 61001
        • Not yet recruiting
        • Basrah Haemoplhilia centre
      • Hillah, Iraq, 51001
        • Enrolling by invitation
        • Hilla Haemophilia centre
      • Karbala, Iraq, 56001
        • Enrolling by invitation
        • Karbala Haemophilia centre
      • Kirkuk, Iraq, 36001
        • Enrolling by invitation
        • Kirkuk Centre for Cancer and Blood Disorders
      • Najaf, Iraq, 54001
        • Enrolling by invitation
        • Najaf Haemophilia Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants received Turoctocog alfa intravenously.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Turoctocog alfa
Participants received turoctocog alfa intravenously.
Drug: Turoctocog alfa
Turoctocog alfa was administered intravenously.
Other Names:
  • NovoEight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
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.
From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
Dose of turoctocog alfa
Time Frame: At month 12 after switching to turoctocog alfa
Measured as international uniit per kilogram (IU/kg).
At month 12 after switching to turoctocog alfa
Haemostatic response to turoctocog alfa
Time Frame: At baseline and at month 12
Measured as excellent, good, moderate, none.
At baseline and at month 12
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.
At month 12 after switching to turoctocog alfa
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.
At month 12 after switching to turoctocog alfa
New target joint
Time Frame: At month 12 after switching to turoctocog alfa
Measured as number resolution (Yes/No) affected joints.
At month 12 after switching to turoctocog alfa
Severity of bleeding
Time Frame: At month 12 after switching to turoctocog alfa
Measured as mild / moderate / severe.
At month 12 after switching to turoctocog alfa

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2024

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7008-7871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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