Mim8 for Hemophilia A
Phase-Based Progress Estimates
Effectiveness
Safety
Hemophilia A+1 More
Mim8 - DrugEligibility
< 18
All Sexes
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Eligibility
< 18
All Sexes
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Study Summary
This study is looking at how Mim8 works compared to other medicines in children with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeds. Mim8 will be injected with a thin needle into the skin. The study will last for about 54-98 weeks, from screening to follow-up visit, In case the participant experiences bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor.
Eligible Conditions
- Hemophilia A
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: From run-in initiation to end of treatment (week -26 to week 52)
Week 52
Consumption of factor product per bleed treatment
Consumption of factor product per bleed treatment (number of injections)
Week 52
Change in participants' treatment burden using the Hemo TEM (Haemophilia treatment experience measure)
Change in physical function domain of PEDS QL (Paediatric Quality of Life inventory) Generic Core Scales
Mim8 plasma concentration
Number of injection site reactions
Number of treated bleeds
Number of treated joint bleeds
Number of treated spontaneous bleeds
Number of treated target joint bleeds
Number of treated traumatic bleeds
Occurrence of anti-Mim8 antibodies
Week 72
Number of treatment emergent adverse events
Week 26
Treatment preference for Mim8 versus previous treatment using Caregiver H PPQ (Caregiver Haemophilia Patient Preference )
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
Mim8
1 of 1
Experimental Treatment
70 Total Participants · 1 Treatment Group
Primary Treatment: Mim8 · No Placebo Group · Phase 3
Mim8
Drug
Experimental Group · 1 Intervention: Mim8 · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from run-in initiation to end of treatment (week -26 to week 52)
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,390 Previous Clinical Trials
2,293,533 Total Patients Enrolled
94 Trials studying Hemophilia A
9,797 Patients Enrolled for Hemophilia A
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
56,031 Total Patients Enrolled
2 Trials studying Hemophilia A
357 Patients Enrolled for Hemophilia A
Eligibility Criteria
Age < 18 · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You must have been informed of the study's purpose and the study-related activities.
You are willing and able to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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