Haemophilia BNCT03690336
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
An observational study of Haemophilia B, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haemophilia B
- What is being tested?
- Nonacog beta pegol
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2018to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with haemophilia B
Who may be able to join
- Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries
Who cannot join
- Not applicable as this is a study collecting third-party data from registries
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United Kingdom1 site
European Haemophilia Safety Surveillance Registry
Sheffield
About this study
The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.
- Conditions
- Haemophilia B
- Being tested
- Nonacog beta pegol
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonacog beta pegolDrug
Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients with haemophilia B | Patients with haemophilia B treated with nonacog beta pegol who report adverse events to the PedNet and EUHASS, and possibly other national or international registries. Receives: Drug: Nonacog beta pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B
Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events)
Measured: From start of data collection (week 0) to end of data collection (after 9 years)
Secondary outcomes (1)
Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B
Number of events (de novo FIX inhibitors more than or equal to 0.6 Bethesda units); anaphylaxis and other allergic reactions; thromboembolic events)
Measured: From start of data collection (week 0) to end of data collection (after 9 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia BStudies 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
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690336
- Sponsor's protocol ID
- NN7999-4413
- Other IDs
- U1111-1212-4050, EUPAS25696
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
- Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
- ClinicalTrials.gov ID
- NCT03690336
- Acronym / sponsor ID
- NN7999-4413
- Conditions
- Haemophilia B
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 Oct 2018 (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 purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with haemophilia B | – | Drug: Nonacog beta pegolPatients with haemophilia B treated with nonacog beta pegol who report adverse events to the PedNet and EUHASS, and possibly other national or international registries. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with haemophilia B
Key inclusion criteria (1 listed)
- Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries
Key exclusion criteria (1 listed)
- Not applicable as this is a study collecting third-party data from registries
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 |
|---|---|---|
| Nonacog beta pegolTreatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician. | Drug | Patients with haemophilia B |
Primary outcome
Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B
Time frame: From start of data collection (week 0) to end of data collection (after 9 years)
Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events)
1 secondary outcome
Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B
Time frame: From start of data collection (week 0) to end of data collection (after 9 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Clinical Transparency (2834) study director
Novo Nordisk A/S
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia B, run by Novo Nordisk A/S at 2 sites in 2 countries.
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 1 inclusion and 1 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: enrolling by invitation, 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 2 sites in Netherlands, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B (time frame: From start of data collection (week 0) to end of data collection (after 9 years)). 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.