Clinical trial NCT06574984: Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients
Official title: Descriptive Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients - An Observational Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-08-28
Enrollment: 900
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants received Turoctocog alfa intravenously.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy
timeFrame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
Secondary outcomes:
measure: ABRs among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy
timeFrame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
measure: Change of primary prophylaxis regimen
timeFrame: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
measure: Dose of turoctocog alfa
timeFrame: At month 12 after switching to turoctocog alfa
measure: Haemostatic response to turoctocog alfa
timeFrame: At baseline and at month 12
measure: Spontaneous ABR
timeFrame: At month 12 after switching to turoctocog alfa
measure: Annualized joint bleed rate (AJBR)
timeFrame: At month 12 after switching to turoctocog alfa
measure: New target joint
timeFrame: At month 12 after switching to turoctocog alfa
measure: Severity of bleeding
timeFrame: At month 12 after switching to turoctocog alfa
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: National centre for Hamophilia
city: Baghdad
country: Iraq
facility: Novo Nordisk Investigational Site
city: Basrah
country: Iraq
facility: Basrah Haemoplhilia centre
city: Hilla
country: Iraq
facility: Hilla Haemophilia centre
city: Karbala
country: Iraq
facility: Karbala Haemophilia centre
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: