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Recruiting Phase 3 Interventional

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A

ClinicalTrials.gov ID: NCT05685238

Public ClinicalTrials.gov record NCT05685238. 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.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 5:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05685238
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
451 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
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
Feb 12, 2023
Primary completion
Jun 29, 2028
Completion
Jun 29, 2028
Last update posted
Jun 29, 2026

2023 – 2028

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
Children's Hospital Los Angeles - Endocrinology Los Angeles California 90027 Recruiting
UC Denver Hemoph & Thrombo Ctr Aurora Colorado 80045 Recruiting
Univ of Miami/SCCC Miami Florida 33136 Recruiting
St Joseph's Hospital Foundation Tampa Florida 33607 Active, not recruiting
Children's Healthcare Atlanta Atlanta Georgia 30329 Recruiting
Rush University Med. Cntr Chicago Illinois 60612 Completed
Rush University Medical Center Chicago Illinois 60612 Not yet recruiting
Indiana Hemophilia-Thromb Ctr Indianapolis Indiana 46260 Completed
University of Iowa_Iowa City Iowa City Iowa 52242 Recruiting
Central Michigan University Detroit Michigan 48201 Recruiting
Univ Hosp Cleveland Med Ctr Cleveland Ohio 44106 Recruiting
Dayton Children Hemostati Ctr Dayton Ohio 45404 Recruiting
Penn State MS Hershey Med Ctr Hershey Pennsylvania 17033-2360 Recruiting
St Christopher Hosp for Child Philadelphia Pennsylvania 19134 Recruiting
Vanderbilt U Med Ctr_Nashville Nashville Tennessee 37212 Recruiting

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 127 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05685238, 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 Jun 29, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05685238 live on ClinicalTrials.gov.

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