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NCT05053139 · ClinicalTrials.gov registry record · Phase 3
A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 281
- Enrollment target
NCT05053139 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 281 participants.
The verdict
NCT05053139, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 281 participants
- Enrollment target
Study Summary
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.
Interventions
- DRUG NNC0365-3769 (Mim8)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2021-12-02 |
| Est. Completion | 2024-12-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05053139
The ClinicalTrials.gov registry entry for NCT05053139 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 281 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) is the first listed.
NCT05053139 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05053139 about?
NCT05053139 is a clinical study titled "A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors". This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor...
What is the current status of trial NCT05053139?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 281 participants. The study started on 2021-12-02. Estimated completion is 2024-12-17.
What interventions are being tested in trial NCT05053139?
The interventions under investigation include: NNC0365-3769 (Mim8) (DRUG).
Who is sponsoring clinical trial NCT05053139?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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