A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors
Public ClinicalTrials.gov record NCT05053139. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05053139
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 281 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2, 2021 (Actual)
- Primary completion
- Mar 11, 2024 (Actual)
- Completion
- Dec 17, 2024 (Actual)
- Last update posted
- Dec 8, 2025
2021 – 2024
United States locations
- U.S. sites
- 34
- U.S. states
- 20
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona H&T Phoenix Child Hosp | Phoenix | Arizona | 85016-7710 | — |
| Hemophilia Treatment Center | Los Angeles | California | 90007 | — |
| Children's Hospital Los Angeles - Endocrinology | Los Angeles | California | 90027 | — |
| Univ of Colorado Sch of Med | Aurora | Colorado | 80045 | — |
| Univ of Miami/SCCC | Miami | Florida | 33136 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| St Joseph's Hospital Foundation | Tampa | Florida | 33607 | — |
| Children HC Atlanta-Adv Pediat | Atlanta | Georgia | 30329 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Memorial Health Univ Med Ctr | Savannah | Georgia | 31404 | — |
| Rush University Med. Cntr | Chicago | Illinois | 60612 | — |
| Indiana Hemophilia-Thromb Ctr | Indianapolis | Indiana | 46260 | — |
| University of Iowa_Iowa City | Iowa City | Iowa | 52242 | — |
| University Of Iowa | Iowa City | Iowa | 52242 | — |
| Children's Hosp-New Orleans | New Orleans | Louisiana | 70118-5720 | — |
| University Of Michigan | Ann Arbor | Michigan | 48109 | — |
| Michigan State University | East Lansing | Michigan | 48823 | — |
| Washington University School of Medicine_St. Louis | St Louis | Missouri | 63110 | — |
| Univ of NE Med Center_Omaha | Omaha | Nebraska | 68105 | — |
| Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | — |
| Torrence Hemby Ped Hem/Onc Ctr | Charlotte | North Carolina | 28203 | — |
| St. Jude Clinic Novant Health | Charlotte | North Carolina | 28204 | — |
| Cincinnati Child's Hsp Med Ctr | Cincinnati | Ohio | 45229 | — |
| Univ Hosp Cleveland Med Ctr | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children Hemostati Ctr | Dayton | Ohio | 45404 | — |
| Penn State MS Hershey Med Ctr | Hershey | Pennsylvania | 17033-2360 | — |
| St Christopher Hosp for Child | Philadelphia | Pennsylvania | 19134 | — |
| Balad Hlth Sys-Welmont CardCVA | Kingsport | Tennessee | 37660 | — |
| Vanderbilt Hemostasis Thrombosis Clinic | Nashville | Tennessee | 37232-9830 | — |
| Children's Medical Center_Dallas | Dallas | Texas | 75235 | — |
| Univ TX Hlth Sci Ctr Houston | Houston | Texas | 77030 | — |
| Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington | 99204 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 129 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05053139, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05053139 live on ClinicalTrials.gov.