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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients - An Observational Retrospective Study
- ClinicalTrials.gov ID
- NCT06574984
- Acronym / sponsor ID
- NN7008-7871
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Turoctocog alfa | – | Drug: Turoctocog alfaParticipants received turoctocog alfa intravenously. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants received Turoctocog alfa intravenously.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients diagnosed with coagulation disorders other than haemophilia A such as Von Willebrand disease
- Patients with documented presence of any FVIII inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turoctocog alfaAlso: NovoEightTuroctocog alfa was administered intravenously. | Drug | Turoctocog alfa |
Primary outcome
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.
8 secondary outcomes
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
Change of primary prophylaxis regimen
Time frame: 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
Haemostatic response to turoctocog alfa
Time frame: At baseline and at month 12
Spontaneous ABR
Time frame: At month 12 after switching to turoctocog alfa
Annualized joint bleed rate (AJBR)
Time frame: At month 12 after switching to turoctocog alfa
New target joint
Time frame: At month 12 after switching to turoctocog alfa
Severity of bleeding
Time frame: At month 12 after switching to turoctocog alfa
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 7 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.