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NCT05685238 · ClinicalTrials.gov registry record · Phase 3
A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)
A Phase 3 study of Haemophilia A and Haemophilia A With Inhibitors, sponsored by Novo Nordisk A/S.
- Active
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
- 20
- Study locations
NCT05685238: Active Phase 3 study of Haemophilia A and Haemophilia A With Inhibitors, sponsored by Novo Nordisk A/S.
NCT05685238 is a Phase 3 study of Haemophilia A and Haemophilia A With Inhibitors that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 451 participants, above the 169-participant average among 8 other Haemophilia A trials with a reported enrollment target (167% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05685238, a Phase 3 study of Haemophilia A and Haemophilia A With Inhibitors, is active but no longer recruiting, sponsored by Novo Nordisk A/S.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in June 2028, whichever comes first. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections and how long time participants take part in the study. While taking part in this study, there are some restrictions about what medicine participants 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.
Primary Outcome
Measured as count of events.
Conditions Studied
Interventions
- DRUG Mim8
Study Locations (20)
Other
- Universitätsklinik für Innere Medizin V - Innsbruck
- Universitätsklinik für Innere Medizin V - Innsbruck
- AKH - Klin. Abt. f. Haematologie u. Haemostaseologie - Vienna
- Cliniques universitaires Saint-Luc - Service Hématologie - Brussels
- UZ Leuven - Kindergeneeskunde - Leuven
Florida
- Univ of Miami/SCCC - Miami
- St Joseph's Hospital Foundation - Tampa
Illinois
- Rush University Med. Cntr - Chicago
- Rush University Medical Center - Chicago
Ohio
- Univ Hosp Cleveland Med Ctr - Cleveland
- Dayton Children Hemostati Ctr - Dayton
Pennsylvania
- Penn State MS Hershey Med Ctr - Hershey
- St Christopher Hosp for Child - Philadelphia
California
- Children's Hospital Los Angeles - Endocrinology - Los Angeles
Colorado
- UC Denver Hemoph & Thrombo Ctr - Aurora
Georgia
- Children's Healthcare Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 3 |
What the registry record for NCT05685238 still lists
NCT05685238 is an interventional study that assigns participants to a tested intervention. The registered 451 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 8 other Haemophilia A trials with a reported enrollment target (167% higher).
The record links to 2 conditions, with Haemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Mim8 is the first listed.
NCT05685238 names 20 study sites across 12 states, led by Other, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05685238 about?
NCT05685238 is a clinical study titled "A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)". This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for u...
What is the current status of trial NCT05685238?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2023-02-13. Estimated completion is 2028-06-30.
What conditions does trial NCT05685238 study?
This clinical trial studies the following conditions: Haemophilia A, Haemophilia A With Inhibitors.
What interventions are being tested in trial NCT05685238?
The interventions under investigation include: Mim8 (DRUG).
Who is sponsoring clinical trial NCT05685238?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05685238 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Haemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05685238's enrollment target sits among peer trials
451 2nd of 8 the highest of 8 other Haemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Haemophilia A 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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