A Research Study Investigating Mim8 in People With Haemophilia A
Public ClinicalTrials.gov record NCT04204408. 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
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769 (Mim8) in Healthy Subjects and in Subjects With Haemophilia A With or Without Factor VIII Inhibitors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector. The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.
Study identification
- NCT ID
- NCT04204408
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 275 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2020 (Actual)
- Primary completion
- Oct 6, 2023 (Actual)
- Completion
- Oct 6, 2023 (Actual)
- Last update posted
- Dec 19, 2025
2020 – 2023
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona H&T Phoenix Child Hosp | Phoenix | Arizona | 85016-7710 | — |
| Children's Hospital Los Angeles - Endocrinology | Los Angeles | California | 90027 | — |
| Children's Healthcare Atlanta | Atlanta | Georgia | 30322 | — |
| Rush University Med. Cntr | Chicago | Illinois | 60612 | — |
| University of Iowa_Iowa City | Iowa City | Iowa | 52242 | — |
| University Of Michigan | Ann Arbor | Michigan | 48109 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Michigan State University | East Lansing | Michigan | 48823 | — |
| St. Jude Clinic Novant Health | Charlotte | North Carolina | 28204 | — |
| Cincinnati Child's Hsp Med Ctr | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children Hemostati Ctr | Dayton | Ohio | 45404 | — |
| Penn State MS Hershey Med Ctr | Hershey | Pennsylvania | 17033-2360 | — |
| Vanderbilt Hemostasis Thrombosis Clinic | Nashville | Tennessee | 37232 | — |
| Versiti, CCBD | 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 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04204408, 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 19, 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 NCT04204408 live on ClinicalTrials.gov.