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A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)
NCT05685238 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05685238
The ClinicalTrials.gov registry entry for NCT05685238 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 451 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 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05685238 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05685238?
The interventions under investigation include: Mim8 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05685238?
This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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