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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: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT05053139 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 281 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Count
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 |
What the finished NCT05053139 record still lists
NCT05053139 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which NNC0365-3769 (Mim8) is the first listed.
NCT05053139 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05053139's enrollment target sits among peer trials
281 1194th of 2000 higher than 806 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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