Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients

NCT06574984 | Recruiting

• 1 other identifier: NN7008-7871
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Congenital Bleeding Disorder; Haemophilia A

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (8)

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

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

• Change of primary prophylaxis regimen

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

• Dose of turoctocog alfa

  At month 12 after switching to turoctocog alfa

• Haemostatic response to turoctocog alfa

  At baseline and at month 12

• Spontaneous ABR

  At month 12 after switching to turoctocog alfa

Study Arms (1)

Turoctocog alfa

Participants received turoctocog alfa intravenously.

Drug: Turoctocog alfa

Interventions

Turoctocog alfa DRUG

Turoctocog alfa was administered intravenously.

Also known as: NovoEight

Turoctocog alfa

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants received Turoctocog alfa intravenously.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (7)

National centre for Hamophilia

Baghdad, 10001, Iraq

ENROLLING BY INVITATION

Novo Nordisk Investigational Site

Baghdad, Iraq

RECRUITING

Basrah Haemoplhilia centre

Basra, 61001, Iraq

NOT YET RECRUITING

Hilla Haemophilia centre

Hillah, 51001, Iraq

ENROLLING BY INVITATION

Karbala Haemophilia centre

Karbala, 56001, Iraq

ENROLLING BY INVITATION

Kirkuk Centre for Cancer and Blood Disorders

Kirkuk, 36001, Iraq

ENROLLING BY INVITATION

Najaf Haemophilia Centre

Najaf, 54001, Iraq

ENROLLING BY INVITATION

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII N8

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: November 10, 2024
• Primary Completion: February 27, 2026
• Study Completion: April 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IR (7)