A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6) (explorer™6)
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ClinicalTrials.gov Identifier: NCT03741881 |
Recruitment Status :
Enrolling by invitation
First Posted : November 15, 2018
Last Update Posted : March 29, 2021
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Condition or disease | Intervention/treatment |
---|---|
Haemophilia A Haemophilia A With Inhibitors Haemophilia B Haemophilia B With Inhibitors | Other: No treatment given |
Study Type : | Observational |
Estimated Enrollment : | 230 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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) |
Actual Study Start Date : | December 18, 2018 |
Estimated Primary Completion Date : | March 17, 2021 |
Estimated Study Completion Date : | September 15, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Patients with haemophilia
Patients with haemophilia A or B and with or without inhibitors
|
Other: No treatment given
Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand). |
- 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
- The number of all bleeding episodes [ Time Frame: From enrolment (week 0) and up to a maximum of 115 weeks ]Count of bleeding episodes

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
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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).
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741881

Study Director: | Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT03741881 |
Other Study ID Numbers: |
NN7415-4322 U1111-1182-3359 ( Other Identifier: World Health Organization (WHO) ) |
First Posted: | November 15, 2018 Key Record Dates |
Last Update Posted: | March 29, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | According to the Novo Nordisk disclosure commitment on novonordisk-trials.com |
URL: | http://novonordisk-trials.com |
Studies a U.S. FDA-regulated Device Product: | No |
Hemophilia A Hemophilia B Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked |