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NCT05878938 · ClinicalTrials.gov registry record · Phase 3
A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT05878938 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 61 participants.
The verdict
NCT05878938, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.
Interventions
- DRUG NNC0365-3769 (Mim8) PPX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2024-07-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05878938
The ClinicalTrials.gov registry entry for NCT05878938 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NNC0365-3769 (Mim8) PPX is the first listed.
NCT05878938 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05878938 about?
NCT05878938 is a clinical study titled "A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)". This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injec...
What is the current status of trial NCT05878938?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2023-06-26. Estimated completion is 2024-07-19.
What interventions are being tested in trial NCT05878938?
The interventions under investigation include: NNC0365-3769 (Mim8) PPX (DRUG).
Who is sponsoring clinical trial NCT05878938?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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