Arm 1 for Hemophilia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novo Nordisk Investigational Site, Merida, MexicoHemophilia+1 MoreMim8 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new medicine (Mim8) to prevent bleeding episodes in people with haemophilia A who have or don’t have inhibitors. Participants will get up to 262 injections of Mim8 over 5.5 years, with restrictions on other medicines.

Eligible Conditions
  • Hemophilia A With Inhibitors
  • Hemophilia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: From visit 8 (week 26) until end of treatment (up to 262 weeks)

Week 283
Number of treatment emergent adverse events
Week 262
Mim8 plasma concentration
Number of injection site reactions
Number of treated bleeding episodes
Number of treated joint bleeding episodes
Number of treated spontaneous bleeding episodes
Number of treated target joint bleeding episodes (arm 2)
Number of treated traumatic bleeding episodes
Occurrence of anti Mim8 antibodies
Week 262
Device handling using haemophilia device assessment tool (HDAT) (applicable for participants in arm 2 only)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm 1
1 of 2
Arm 2
1 of 2

Experimental Treatment

425 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 1 · No Placebo Group · Phase 3

Arm 1
Drug
Experimental Group · 1 Intervention: Mim8 · Intervention Types: Drug
Arm 2
Drug
Experimental Group · 1 Intervention: Mim8 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from visit 8 (week 26) until end of treatment (up to 262 weeks)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,420 Previous Clinical Trials
2,312,789 Total Patients Enrolled
1 Trials studying Hemophilia
100 Patients Enrolled for Hemophilia
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
26 Previous Clinical Trials
507,860 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

On what scale is this clinical trial being conducted?

"Currently, 4 distinct medical facilities are involved in this research. These include Chicago, Iowa City and Dayton among others. To limit the need for travel during participation, it is beneficial to select a clinic near your area of residence." - Anonymous Online Contributor

Unverified Answer

What potential risks does Arm 1 pose to participants?

"Arm 1 was assigned a score of 3, indicating its safety is supported by prior clinical data and multiple rounds of evidence." - Anonymous Online Contributor

Unverified Answer

Is enrollment still ongoing for this experiment?

"According to the clinicaltrials.gov database, this trial is no longer actively seeking applicants as its last update was on January 19th 2023. Despite this, there are 90 other research studies that are currently enrolling patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.