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Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

Study acronym: explorer7
StatusActive, Not Recruiting
PhasePhase 3
Started2019-10-21
View on ClinicalTrials.gov ↗
This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about seven years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (31 December 2026 at the latest). The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

Amendment record

Amended 98 times since 2019-09-06; most recent filed 2026-09-07. The 50 most recent of 99 record versions are listed below. See every version on ClinicalTrials.gov ↗

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-09-15.

2026-09-07
Amendment Study Status v98
2026-06-11
Amendment Study Status, Contacts/Locations v97
2026-03-23
Amendment Study Status, Contacts/Locations v96
2025-12-15
Amendment Study Status, Contacts/Locations v95
2025-10-09
Amendment Study Status, Contacts/Locations v94
2025-08-28
Amendment Study Status, Contacts/Locations v93
2025-05-20
Amendment Study Status, Contacts/Locations v92
2025-04-09
Amendment Study Status, Outcome Measures (Results) v91
2025-03-03
Amendment Study Status, Outcome Measures, Contacts/Locations, Outcome Measures (Results) v90
2025-01-14
Amendment Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v89
2024-09-18
Amendment Study Status, Contacts/Locations v88
2024-08-19
Amendment Study Status v87
2024-07-12
Amendment Study Status v86
2024-06-20
Amendment Study Status, Contacts/Locations v85
2024-03-25
Amendment Study Status v84
2024-02-26
Amendment Study Status, Contacts/Locations v83
2023-12-04
Amendment Study Status v82
2023-11-27
Amendment Study Status v81
2023-10-29
Amendment Study Status, Contacts/Locations v80
2023-09-26
Amendment Study Status v79
2023-09-21
Amendment Study Status, Contacts/Locations v78
2023-08-24
Amendment Study Status v77
2023-08-08
Amendment Study Status, Contacts/Locations v76
2023-04-21
Amendment Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations v75
2023-03-24
Amendment Study Status, Contacts/Locations v74
2023-02-03
Amendment Study Status v73
2022-12-29
Amendment Study Status, Eligibility v72
2022-12-21
Amendment Study Status, Eligibility, Contacts/Locations v71
2022-10-27
Amendment Study Status, Contacts/Locations v70
2022-09-15
Amendment Study Status v69
2022-03-18
Amendment Study Status v68
2022-02-09
Amendment Study Status, Contacts/Locations v67
2021-09-03
Amendment Study Status, Contacts/Locations v66
2021-08-11
Amendment Study Status v65
2021-06-10
Amendment Study Status v64
2021-06-04
Amendment Study Status, Contacts/Locations v63
2021-05-31
Amendment Study Status v62
2021-05-25
Amendment Study Status v61
2021-05-14
Amendment RecruitingActive, Not Recruiting Study Status, Contacts/Locations v60
2021-04-27
Amendment Study Status, Contacts/Locations v59
2021-04-21
Amendment Study Status, Contacts/Locations v58
2021-04-08
Amendment Study Status, Outcome Measures, Contacts/Locations v57
2021-03-23
Amendment Study Status, Contacts/Locations v56
2021-03-18
Amendment Study Status, Contacts/Locations v55
2021-03-16
Amendment Study Status, Contacts/Locations v54
2021-03-11
Amendment Study Status, Contacts/Locations v53
2021-03-08
Amendment Study Status, Contacts/Locations v52
2021-03-03
Amendment Study Status, Contacts/Locations v51
2021-03-02
Amendment Study Status, Contacts/Locations v50
2021-02-26
Amendment Study Status, Contacts/Locations v49
Trial Details
NCT Number NCT04083781
Lead Sponsor Novo Nordisk A/S
Conditions Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
Enrollment 134 participants
Start Date 2019-10-21
Primary Completion 2021-12-27 (estimated)
Study Completion 2027-02-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-09