Haemophilia ANCT05621746
An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct
An observational study of Haemophilia A, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
This study will collect information on the long term health of joints in people with haemophilia A who have started treatment with Esperoct within twelve months prior to participation to the study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Haemophilia A
- What is being tested?
- Esperoct
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2022to 30 Apr 2026
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: Participants with Haemophilia A
Who may be able to join
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male, greater than or equal to 18 years of age at the time of signing informed consent, diagnosed with severe (FVIII activity below 1%) or moderate congenital haemophilia A (FVIII activity 1-5%).
- The decision to initiate treatment with commercially available Esperoct has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
- Switched, within two months prior to enrolment, OR planned to switch, within one month post enrolment, to prophylaxis treatment with Esperoct from previous therapy; the decision to initiate treatment with Esperoct must be made prior to and independently from the decision to enrol in the study.
- Must have baseline data (HJHS, target joints, and medical history) collected in routine clinical practice within two months prior or up to one month post switch to Esperoct therapy.
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Previous terminated treatment regimen with Esperoct prophylaxis.
- Current or previously terminated treatment regimen with Esperoct on-demand.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Previous participation in a clinical trial within the 30 days prior to switching to Esperoct.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Interventional Study of the Change in Joint Health in Adult Patients With Haemophilia A After Switching to Prophylaxis With Turoctocog Alfa Pegol (N8-GP)
This study will collect information on the long term health of joints in people with haemophilia A who have started treatment with Esperoct within twelve months prior to participation to the study. This study is conducted to look at how joint health of people with haemophilia changes over time when they are receiving the medicine Esperoct. The participants will get Esperoct as prescribed to the participants by the study doctor. The participant's treatment will not be affected by their involvement in the study. Every six months, the participants will be asked to answer some questionnaires about their joints, their pain and their ability to be physically active. Their participation in the study will last for no more than 2 years. The participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
- Conditions
- Haemophilia A
- Being tested
- Esperoct
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsperoctDrug
Also called Turoctocog alfa pegol (N8-GP)
Participants will be treated with commercially available Esperoct for a total study duration of 24 months according to the local label and local routine clinical practice at the discretion of the physician. The decision to switch to Esperoct will be made prior to and separate from the decision to enrol in the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Haemophilia A | Participants will be treated with commercially available Esperoct for a total study duration of 24 months according to the local label and local routine clinical practice at the discretion of the physician. The decision to switch to Esperoct will be made prior to and separate from the decision to enrol in the study. Receives: Drug: Esperoct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in haemophilia joint health score (HJHS)
Measured as units on a score. The scoring range of the HJHS is from 0 (normal, healthy joints) to 124 (maximum severity). A sustained HJHS is defined as a change in total score of less than or equal to (<=) 2 points over 24 months.
Measured: From date of switch to end of study (up to 24 months)
Secondary outcomes (6)
The number of bleeding episodes requiring coagulation Factor VIII (FVIII) treatment
Measured as episodes
Measured: From baseline to end of study (up to 24 months)
Number of target joints
Measured as number of target joints. Target joints is defined according to the International Society on Thrombosis and Haemostasis (ISTH) as any joint with greater than or equal to (>=) 3 bleeding episodes in the same joint within a 6-month period.
Measured: From baseline to end of study (up to 24 months)
Resolution of any target joints (Yes/No)
Measured as number of resolutions. Target joint resolution is defined according to the ISTH as previously diagnosed target joint that has <=2 spontaneous bleeds in the target joint over 12 month.
Measured: From baseline to end of study (up to 24 months)
Change in patient reported Problem Joint score
Measured in score of problem joints (PJs). A PJ is defined as having chronic joint pain and/or limited range of movement due to compromised joint integrity (i.e. chronic synovitis and/or hemophilic arthropathy). PJ scores are stratified: none, 1 PJ, and 2+ PJs.
Measured: From baseline to end of study (up to 24 months)
Change in patient reported pain scores (Brief Pain Inventory)
Measured as units on a score. The BPI assesses pain at its "worst," "least," "average," and "current pain".
Measured: From baseline to end of study (up to 24 months)
Change in physical function and activity measured using patient reported outcome questionnaires (Short Form-36)
Measured as units on a score. Short form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participants's overall health-related quality of life (HRQoL). Scores range from 0-100 (where higher scores indicate a better HRQoL)
Measured: From baseline to end of study (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start23 Nov 2022
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 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
- NCT05621746
- Sponsor's protocol ID
- NN7088-4928
- Other IDs
- U1111-1271-9209
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study of the Change in Joint Health in Adult Patients With Haemophilia A After Switching to Prophylaxis With Turoctocog Alfa Pegol (N8-GP)
- ClinicalTrials.gov ID
- NCT05621746
- Acronym / sponsor ID
- NN7088-4928
- Conditions
- Haemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 18 Nov 2022 (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.
This study will collect information on the long term health of joints in people with haemophilia A who have started treatment with Esperoct within twelve months prior to participation to the study. This study is conducted to look at how joint health of people with haemophilia changes over time when they are receiving the medicine Esperoct. The participants will get Esperoct as prescribed to the participants by the study doctor. The participant's treatment will not be affected by their involvement in the study. Every six months, the participants will be asked to answer some questionnaires about their joints, their pain and their ability to be physically active. Their participation in the study will last for no more than 2 years. The participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Haemophilia A | – | Drug: EsperoctParticipants will be treated with commercially available Esperoct for a total study duration of 24 months according to the local label and local routine clinical practice at the discretion of the physician. The decision to switch to Esperoct will be made prior to and separate from the decision to enrol in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Participants with Haemophilia A
Key inclusion criteria (5 listed)
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male, greater than or equal to 18 years of age at the time of signing informed consent, diagnosed with severe (FVIII activity below 1%) or moderate congenital haemophilia A (FVIII activity 1-5%).
- The decision to initiate treatment with commercially available Esperoct has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
- Switched, within two months prior to enrolment, OR planned to switch, within one month post enrolment, to prophylaxis treatment with Esperoct from previous therapy; the decision to initiate treatment with Esperoct must be made prior to and independently from the decision to enrol in the study.
- Must have baseline data (HJHS, target joints, and medical history) collected in routine clinical practice within two months prior or up to one month post switch to Esperoct therapy.
Key exclusion criteria (5 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Previous terminated treatment regimen with Esperoct prophylaxis.
- Current or previously terminated treatment regimen with Esperoct on-demand.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Previous participation in a clinical trial within the 30 days prior to switching to Esperoct.
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 |
|---|---|---|
| EsperoctAlso: Turoctocog alfa pegol (N8-GP)Participants will be treated with commercially available Esperoct for a total study duration of 24 months according to the local label and local routine clinical practice at the discretion of the physician. The decision to switch to Esperoct will be made prior to and separate from the decision to enrol in the study. | Drug | Participants with Haemophilia A |
Primary outcome
Change in haemophilia joint health score (HJHS)
Time frame: From date of switch to end of study (up to 24 months)
Measured as units on a score. The scoring range of the HJHS is from 0 (normal, healthy joints) to 124 (maximum severity). A sustained HJHS is defined as a change in total score of less than or equal to (<=) 2 points over 24 months.
6 secondary outcomes
The number of bleeding episodes requiring coagulation Factor VIII (FVIII) treatment
Time frame: From baseline to end of study (up to 24 months)
Number of target joints
Time frame: From baseline to end of study (up to 24 months)
Resolution of any target joints (Yes/No)
Time frame: From baseline to end of study (up to 24 months)
Change in patient reported Problem Joint score
Time frame: From baseline to end of study (up to 24 months)
Change in patient reported pain scores (Brief Pain Inventory)
Time frame: From baseline to end of study (up to 24 months)
Change in physical function and activity measured using patient reported outcome questionnaires (Short Form-36)
Time frame: From baseline to end of study (up to 24 months)
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 8 Oct 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'
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A, run by Novo Nordisk A/S at 1 site in Canada.
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 5 inclusion and 5 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Change in haemophilia joint health score (HJHS) (time frame: From date of switch to end of study (up to 24 months)). 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 8 Oct 2026.