Haemophilia Aexplorer™6NCT03741881
A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)
An observational study of Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 143 sites in 36 countries.
Trial summary
This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Read more about this study
- Who is it for?
- Ages 12 years and older, men only
- Conditions the study is for
- Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- What is being tested?
- No treatment given
- How many people
- 231 participants
- Where
- 143 sitesin 36 countries
- Study dates
- 18 Dec 2018to 25 Oct 2021
- 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 12 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with haemophilia A or B and with or without inhibitors
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.
- Male, age equal to or above 12 years at the time of signing informed consent.
- Patients with congenital haemophilia with inhibitors treated with FEIBA® prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1).
- (For Turkey only: Patients with congenital haemophilia with inhibitors treated with by-passing agents prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1)).
- Severe (FVIII activity below 1%) congenital haemophilia A or severe/moderate (FIX activity equal to or below 2%) congenital haemophilia B, or congenital haemophilia A or B of any severity, with a presence or history of inhibitor (equal to or above 0.6 Bethesda Unit (BU)), based on medical records
- Patients with CHwI treated on-demand: equal to or above 6 treated (with bypassing agent) bleeding episodes within 24 weeks (or equal to or above 12 during 52 weeks) before screening (visit 1) and patients with severe congenital HA/HB treated on-demand: equal to or above 5 treated (with factor product) bleeding episodes within 24 weeks (or equal to or above 10 during 52 weeks) before screening (visit 1).
Who cannot join
- Known or suspected hypersensitivity to monoclonal antibodies.
- Previous participation in this study. Participation is defined as signed informed consent.
- Any disorder, except for conditions associated with congenital haemophilia, which in the physician's opinion might jeopardise patient's safety or compliance with the protocol.
- Previous treatment with concizumab. Previous treatment is defined as two or more doses administered.
- Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.
- Current or planned treatment with emicizumab.
Show all 9Show fewer
- Any known congenital or acquired coagulation disorder other than congenital haemophilia.
- History of thromboembolic disease, current clinical signs of or treatment for thromboembolic disease, or at high risk of thromboembolic disease as judged by the investigator.
- Presence or history of malignant neoplasm within 5 years prior to the day of screening.
Trial locations and contacts
143 sites in 36 countries.
143 sites in 36 countries
United States29 sites
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87131
Novo Nordisk Investigational Site
Atlanta, Georgia, 30322
Novo Nordisk Investigational Site
Augusta, Georgia, 30912
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Charleston, South Carolina, 29425
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28203
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28204
Novo Nordisk Investigational Site
Charlottesville, Virginia, 22908
Novo Nordisk Investigational Site
Chicago, Illinois, 60612
Novo Nordisk Investigational Site
Cleveland, Ohio, 44106
Novo Nordisk Investigational Site
Dayton, Ohio, 45404
Novo Nordisk Investigational Site
Detroit, Michigan, 48201
Novo Nordisk Investigational Site
East Lansing, Michigan, 48823
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46260
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89135
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
Macon, Georgia, 31201
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53226
Novo Nordisk Investigational Site
Nashville, Tennessee, 37232-9830
Novo Nordisk Investigational Site
Newark, New Jersey, 07102
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19134
Novo Nordisk Investigational Site
Sacramento, California, 95817
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84113
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
St Louis, Missouri, 63110
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, 20007
Japan15 sites
Novo Nordisk Investigational Site
Aichi, 466-8560
Novo Nordisk Investigational Site
Hiroshima, 734-8551
Novo Nordisk Investigational Site
Hyōgo, 654-0047
Novo Nordisk Investigational Site
Kagoshima, 890-8760
Novo Nordisk Investigational Site
Kanagawa, 216-8511
Novo Nordisk Investigational Site
Kyoto, 602-8566
Novo Nordisk Investigational Site
Mie, 514-8507
Novo Nordisk Investigational Site
Nara, 634-8522
Novo Nordisk Investigational Site
Niigata, 941-8502
Novo Nordisk Investigational Site
Osaka, 546-0006
Novo Nordisk Investigational Site
Saitama, 330-8777
Novo Nordisk Investigational Site
Saitama, 350-0495
Novo Nordisk Investigational Site
Shizuoka, 420-8660
Novo Nordisk Investigational Site
Tokyo, 157-8535
Novo Nordisk Investigational Site
Tokyo, 167-0035
France9 sites
Novo Nordisk Investigational Site
Brest, 29609
Novo Nordisk Investigational Site
Bron, 69677
Novo Nordisk Investigational Site
Caen, 14033
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, 94270
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Paris, 75015
Novo Nordisk Investigational Site
Rennes, 35033
Novo Nordisk Investigational Site
Saint-Etienne, 42055
Turkey (Türkiye)9 sites
Novo Nordisk Investigational Site
Adana, 01130
Novo Nordisk Investigational Site
Ankara, 06230
Novo Nordisk Investigational Site
Ankara, 06500
Novo Nordisk Investigational Site
Antalya, 01010
Novo Nordisk Investigational Site
Bornova-IZMIR, 35100
Novo Nordisk Investigational Site
Capa-ISTANBUL, 35100
Novo Nordisk Investigational Site
Edirne, 22030
Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Samsun
United Kingdom7 sites
Novo Nordisk Investigational Site
Belfast, BT9 7AB
Novo Nordisk Investigational Site
Birmingham, B15 2TH
Novo Nordisk Investigational Site
London, NW3 2QG
Novo Nordisk Investigational Site
London, WC1N 3HR
Novo Nordisk Investigational Site
Manchester, M13 9WL
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Sheffield, S10 2JF
South Korea6 sites
Novo Nordisk Investigational Site
Busan, 49241
Novo Nordisk Investigational Site
Daejeon, 302-799
Novo Nordisk Investigational Site
Daejeon, 361-711
Novo Nordisk Investigational Site
Jeju-do, 63241
Novo Nordisk Investigational Site
Seoul, 03722
Novo Nordisk Investigational Site
Seoul, 05278
Canada5 sites
Novo Nordisk Investigational Site
Calgary, Alberta, T2N 2T9
Novo Nordisk Investigational Site
Hamilton, Ontario, L8N 3Z5
Novo Nordisk Investigational Site
Hamilton, Ontario, L8S 4K1
Novo Nordisk Investigational Site
Saint John, New Brunswick, E2L 4L4
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6
India5 sites
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560034
Novo Nordisk Investigational Site
Kolkata, West Bengal, 70014
Novo Nordisk Investigational Site
New Dehli, New Delhi, 110029
Novo Nordisk Investigational Site
Pune, Maharashtra, 411004
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, 632004
Italy5 sites
Novo Nordisk Investigational Site
Castelfranco Veneto, 31033
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Udine, 33100
Novo Nordisk Investigational Site
Verona, 37126
Spain5 sites
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Málaga, 29010
Novo Nordisk Investigational Site
Oviedo, 33011
Novo Nordisk Investigational Site
Seville, 41013
Novo Nordisk Investigational Site
Valencia, 46026
Poland4 sites
Novo Nordisk Investigational Site
Krakow, 31-501
Novo Nordisk Investigational Site
Lublin, 20-081
Novo Nordisk Investigational Site
Lublin, 20-093
Novo Nordisk Investigational Site
Warsaw, 02-776
Russia4 sites
Novo Nordisk Investigational Site
Krasnodar, 350007
Novo Nordisk Investigational Site
Moscow, 119049
Novo Nordisk Investigational Site
Moscow, 125167
Novo Nordisk Investigational Site
Saint Petersburg, 191186
Serbia4 sites
Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Belgrade, 11070
Novo Nordisk Investigational Site
Kragujevac, 34000
Novo Nordisk Investigational Site
Novi Sad, 21000
Australia3 sites
Novo Nordisk Investigational Site
Melbourne, Victoria, 3004
Novo Nordisk Investigational Site
Murdoch, Western Australia, 6150
Novo Nordisk Investigational Site
Parkville, Victoria, 3052
Bulgaria3 sites
Novo Nordisk Investigational Site
Plovdiv, 4002
Novo Nordisk Investigational Site
Sofia, 1527
Novo Nordisk Investigational Site
Varna, 9010
South Africa3 sites
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4013
Novo Nordisk Investigational Site
Parktown, Johannesburg, Gauteng, 2193
Novo Nordisk Investigational Site
Polokwane, Limpopo, 0699
Algeria2 sites
Novo Nordisk Investigational Site
Algiers, 16000
Novo Nordisk Investigational Site
Constantine, 25000
Croatia2 sites
Novo Nordisk Investigational Site
Zagreb, 10 000
Novo Nordisk Investigational Site
Zagreb, 10000
Germany2 sites
Novo Nordisk Investigational Site
Bonn, 53127
Novo Nordisk Investigational Site
Homburg, 66421
Greece2 sites
Novo Nordisk Investigational Site
Athens, GR-11527
Novo Nordisk Investigational Site
Thessaloniki, GR 54642
Lithuania2 sites
Novo Nordisk Investigational Site
Vilnius, 08406
Novo Nordisk Investigational Site
Vilnius, LT-08661
Sweden2 sites
Novo Nordisk Investigational Site
Malmö, 205 02
Novo Nordisk Investigational Site
Solna, 171 64
Ukraine2 sites
Novo Nordisk Investigational Site
Kyiv, 01135
Novo Nordisk Investigational Site
Lviv, 79044
Bosnia and Herzegovina1 site
Novo Nordisk Investigational Site
Banja Luka, 78000
About this study
Official title: A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)
This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.
- Conditions
- Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
- Being tested
- No treatment given
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).
| Study group | Role | What they receive |
|---|---|---|
| Patients with haemophilia | Patients with haemophilia A or B and with or without inhibitors Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of treated bleeding episodes
Count of treated bleeding episodes
Measured: From enrolment (week 0) and up to a maximum of 115 weeks
Secondary outcomes (1)
The number of all bleeding episodes
Count of bleeding episodes
Measured: From enrolment (week 0) and up to a maximum of 115 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start18 Dec 2018
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741881
- Sponsor's protocol ID
- NN7415-4322
- Other IDs
- U1111-1182-3359
- Acronym
- explorer™6
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2018
- Last updated
- 23 Nov 2021
- 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
Publications
Wheeler AP, Abraham A, Barnes C, Brown Frandsen R, d'Oiron R, Eichler H, Hampton K, Lopez-Jaime FJ, Lyu CJ, Tavares CMM, Nogami K, Sutton C, Windyga J, Zulfikar B, Castaman G. Real-World Unmet Needs of Patients With Haemophilia A and Haemophilia B With or Without Inhibitors: End-of-Study Results From the explorer6 Non-Interventional Study. Haemophilia. 2025 Sep;31(5):903-911. doi: 10.1111/hae.70051. Epub 2025 May 5.
PubMed 40323006
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)
- ClinicalTrials.gov ID
- NCT03741881
- Acronym / sponsor ID
- explorer™6 / NN7415-4322
- Conditions
- Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 15 Nov 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.
This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with haemophilia | – | Other: No treatment givenPatients with haemophilia A or B and with or without inhibitors |
Who may qualify
- Ages
- 12 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with haemophilia A or B and with or without inhibitors
Key inclusion criteria (6 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.
- Male, age equal to or above 12 years at the time of signing informed consent.
- Patients with congenital haemophilia with inhibitors treated with FEIBA® prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1).
- (For Turkey only: Patients with congenital haemophilia with inhibitors treated with by-passing agents prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1)).
- Severe (FVIII activity below 1%) congenital haemophilia A or severe/moderate (FIX activity equal to or below 2%) congenital haemophilia B, or congenital haemophilia A or B of any severity, with a presence or history of inhibitor (equal to or above 0.6 Bethesda Unit (BU)), based on medical records
Key exclusion criteria (9 listed)
- Known or suspected hypersensitivity to monoclonal antibodies.
- Previous participation in this study. Participation is defined as signed informed consent.
- Any disorder, except for conditions associated with congenital haemophilia, which in the physician's opinion might jeopardise patient's safety or compliance with the protocol.
- Previous treatment with concizumab. Previous treatment is defined as two or more doses administered.
- Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during 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 givenParticipants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand). | Other | Patients with haemophilia |
Primary outcome
The number of treated bleeding episodes
Time frame: From enrolment (week 0) and up to a maximum of 115 weeks
Count of treated bleeding episodes
1 secondary outcome
The number of all bleeding episodes
Time frame: From enrolment (week 0) and up to a maximum of 115 weeks
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 23 Nov 2021.
- Derived from this study: PubMed 40323006Wheeler AP, Abraham A, Barnes C, Brown Frandsen R, d'Oiron R, Eichler H, Hampton K, Lopez-Jaime FJ, Lyu CJ, Tavares CMM, Nogami K, Sutton C, Windyga J, Zulfikar B, Castaman G. Real-World Unmet Needs of Patients With Haemophilia A and Haemophilia B With or Without Inhibitors: End-of-Study Results From the explorer6 Non-Interventional Study. Haemophilia. 2025 Sep;31(5):903-911. doi: 10.1111/hae.70051. Epub 2025 May 5.
- 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 Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
143 sites in 36 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 143 sites in 36 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 6 inclusion and 9 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 143 sites in United States, Japan, France, Turkey (Türkiye), United Kingdom and 31 more countries. 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?
The number of treated bleeding episodes (time frame: From enrolment (week 0) and up to a maximum of 115 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741881, which also lists 1 linked publication.
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 23 Nov 2021.