Congenital Bleeding DisorderNCT06574984
Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 7 sites in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A
- What is being tested?
- Turoctocog alfa
- Type of treatment
- Injection or infusion
- How many people
- 329 participants
- Where
- 7 sitesIraq
- Study dates
- 10 Nov 2024to 4 Nov 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants received Turoctocog alfa intravenously.
Who may be able to join
- 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
Who cannot join
- Patients diagnosed with coagulation disorders other than haemophilia A such as Von Willebrand disease
- Patients with documented presence of any FVIII inhibitor
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Iraq7 sites
National centre for Hamophilia
Baghdad, 10001
Novo Nordisk Investigational Site
Baghdad
Basrah Haemoplhilia centre
Basra, 61001
Hilla Haemophilia centre
Hillah, 51001
Karbala Haemophilia centre
Karbala, 56001
Kirkuk Centre for Cancer and Blood Disorders
Kirkuk, 36001
Najaf Haemophilia Centre
Najaf, 54001
About this study
Official title: 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.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Being tested
- Turoctocog alfa
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turoctocog alfaDrug
Also called NovoEight
Turoctocog alfa was administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Turoctocog alfa | Participants received turoctocog alfa intravenously. Receives: Drug: Turoctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
Change of primary prophylaxis regimen
Measured as Yes/No.
Measured: From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
Dose of turoctocog alfa
Measured as international uniit per kilogram (IU/kg).
Measured: At month 12 after switching to turoctocog alfa
Haemostatic response to turoctocog alfa
Measured as excellent, good, moderate, none.
Measured: At baseline and at month 12
Spontaneous ABR
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.
Measured: At month 12 after switching to turoctocog alfa
Annualized joint bleed rate (AJBR)
Measured as number of reported joint bleeding episodes divided by the observation period in months multiplied by 12.
Measured: At month 12 after switching to turoctocog alfa
New target joint
Measured as number resolution (Yes/No) affected joints.
Measured: At month 12 after switching to turoctocog alfa
Severity of bleeding
Measured as mild / moderate / severe.
Measured: At month 12 after switching to turoctocog alfa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start10 Nov 2024
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574984
- Sponsor's protocol ID
- NN7008-7871
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com