HaemophiliaNCT07163260
Defeat Rare Disease in Asia and Pacific (APAC) DRDA - Haemophilia
An observational study of Haemophilia, run by Novo Nordisk A/S at 4 sites in 4 countries.
Trial summary
This study will help to better understand the course of disease in people with haemophilia (A or B [with or without inhibitors]) and the haemophilia care scenario in the selected countries and the experience so far in dealing with the condition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haemophilia
- What is being tested?
- No treatment given
- How many people
- 244 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 31 Jan 2025to 19 Dec 2025
- 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
- Child, Adult, Older adult
Study population: The study will enroll 3 types of participant categories: 1. Experienced/senior treating physicians i.e., haematologists, paediatric haematologist and physicians treating patients with haemophilia (PWH) 2. Patient organisations (representatives of patient organisations), defined as the organisations working closely to support PWH at a national/regional level 3. Patients/caregivers.
Who may be able to join
- For Experienced/Senior Treating Physicians
- Experienced/senior haematologist treating haemophilia (adult or paediatric) or physician treating patients with haemophilia. (PWH), with greater than 5 years of experience.
- Able to communicate in English or country specific language.
- Agree/sign informed consent before data collection. For Patients Organisations
- Patient organisation supporting haemophilia.
- Expert having greater than 3 years of work experience with the patient organisation.
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- Expert level understanding of haemophilia landscape and care pathway in the relevant country.
- Able to communicate in English or country specific language.
- Agree/sign informed consent before data collection. For Patients/Caregivers
- Patients of all age groups, diagnosed with haemophilia A or haemophilia B (with or without inhibitors) for greater than 2 years.
- For patients less than 18 years of age (*less than 19 years for South Korea), their caregivers aged greater than or equal to 18 years (*greater than or equal to19 years for South Korea) should sign the informed consent.
- For South Korea, the adult age is 19 years.
- Able to communicate in English or country specific language.
- Agree/sign informed consent before data collection.
Who cannot join
- There is no explicit exclusion criterion in this study, thus any participants group who answers "no" to any of the inclusion criteria will be excluded from the study.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
About this study
This study will help to better understand the course of disease in people with haemophilia (A or B [with or without inhibitors]) and the haemophilia care scenario in the selected countries and the experience so far in dealing with the condition. This is a survey-based study; hence no medications or other treatments will be provided to participants as a part of this study.
- Conditions
- Haemophilia
- Being tested
- No treatment given
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| Experienced/Senior Treating Physicians | This group includes haematologists, paediatric haematologist and physicians treating patients with haemophilia (PWH) Receives: Other: No treatment given | |
| Patients Organisations | This group includes the organisations working closely to support patient with haemophillia (PWH) at a national/regional level Receives: Other: No treatment given | |
| Patients/Caregivers | This group includes patients with haemophilia and caregivers managing patients with haemophilia Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated prevalence of haemophilia
Proportion [%] of individuals in a population
Measured: From start of data collection to end of data collection (approximately 5 months)
Estimated incidence of haemophilia
Number of new cases of haemophilia
Measured: From start of data collection to end of data collection (approximately 5 months)
Estimated proportion of patients with haemophilia (PWH) who develop inhibitors (%)
proportion [%] of individuals in a population
Measured: From start of data collection to end of data collection (approximately 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start31 Jan 2025
- Primary completion19 Dec 2025 (estimated)
- Study completion19 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies 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
- Cross-sectional
- Enrolment
- 244 participants (estimated)
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
- NCT07163260
- Sponsor's protocol ID
- DAS-8107
- Other IDs
- U1111-1303-7372
- Status last verified
- Oct 2025
- First submitted
- 6 Aug 2025
- Last updated
- 24 Oct 2025
- 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 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defeat Rare Disease in Asia and Pacific (APAC) DRDA - Haemophilia
- ClinicalTrials.gov ID
- NCT07163260
- Acronym / sponsor ID
- DAS-8107
- Conditions
- Haemophilia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 19 Dec 2025 (estimated)
- First posted
- 9 Sep 2025 (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 help to better understand the course of disease in people with haemophilia (A or B [with or without inhibitors]) and the haemophilia care scenario in the selected countries and the experience so far in dealing with the condition. This is a survey-based study; hence no medications or other treatments will be provided to participants as a part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experienced/Senior Treating Physicians | – | Other: No treatment givenThis group includes haematologists, paediatric haematologist and physicians treating patients with haemophilia (PWH) |
| Patients Organisations | – | Other: No treatment givenThis group includes the organisations working closely to support patient with haemophillia (PWH) at a national/regional level |
| Patients/Caregivers | – | Other: No treatment givenThis group includes patients with haemophilia and caregivers managing patients with haemophilia |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will enroll 3 types of participant categories: 1. Experienced/senior treating physicians i.e., haematologists, paediatric haematologist and physicians treating patients with haemophilia (PWH) 2. Patient organisations (representatives of patient organisations), defined as the organisations working closely to support PWH at a national/regional level 3. Patients/caregivers.
Key inclusion criteria (14 listed)
- For Experienced/Senior Treating Physicians
- Experienced/senior haematologist treating haemophilia (adult or paediatric) or physician treating patients with haemophilia. (PWH), with greater than 5 years of experience.
- Able to communicate in English or country specific language.
- Agree/sign informed consent before data collection. For Patients Organisations
- Patient organisation supporting haemophilia.
Key exclusion criteria (1 listed)
- There is no explicit exclusion criterion in this study, thus any participants group who answers "no" to any of the inclusion criteria will be excluded from the study.
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 |
|---|---|---|
| No treatment givenNo treatment given | Other | Experienced/Senior Treating Physicians, Patients Organisations, Patients/Caregivers |
Primary outcome
Estimated prevalence of haemophilia
Time frame: From start of data collection to end of data collection (approximately 5 months)
Proportion [%] of individuals in a population
Estimated incidence of haemophilia
Time frame: From start of data collection to end of data collection (approximately 5 months)
Number of new cases of haemophilia
Estimated proportion of patients with haemophilia (PWH) who develop inhibitors (%)
Time frame: From start of data collection to end of data collection (approximately 5 months)
proportion [%] of individuals in a population
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 24 Oct 2025.
- 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 (dept. 2834) study director
Novo Nordisk A/S
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia, run by Novo Nordisk A/S at 4 sites in 4 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 14 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 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, Malaysia, South Korea, Thailand. 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?
Estimated prevalence of haemophilia (time frame: From start of data collection to end of data collection (approximately 5 months)). The study lists 3 primary outcomes in all. 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 24 Oct 2025.