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Replacement Therapy
Mim8 for Hemophilia A (FRONTIER 5 Trial)
Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from visit 2 (week 0) until week 26
Awards & highlights
FRONTIER 5 Trial Summary
This trial looks at how safe it is to switch from emicizumab to Mim8 for people with haemophilia A. It tests how often Mim8 needs to be taken, and lasts 6-12 months with some restrictions on medicine use.
Who is the study for?
This trial is for males and females, 12 years or older with haemophilia A who have been treated with emicizumab for at least 8 weeks. They must be willing to switch to Mim8 and follow the study procedures. Excluded are those with hypersensitivity to similar drugs, other coagulation disorders, planned surgeries during the study, liver or kidney issues, pregnant or breastfeeding women, and anyone not using effective contraception.Check my eligibility
What is being tested?
The safety of switching from Emicizumab (a current treatment) to Mim8 (a new medicine) in preventing bleeding in people with haemophilia A is being tested. Participants will self-inject Mim8 under their skin at different frequencies chosen in consultation with a doctor over a period of about half a year.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants should watch out for any signs of allergic reactions due to known sensitivities. The restrictions on certain conditions suggest potential risks like increased bleeding or thrombosis.
FRONTIER 5 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from visit 2 (week 0) until week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from visit 2 (week 0) until week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treatment-emergent adverse events
Secondary outcome measures
Change in participants' treatment burden using the Hemophilia treatment experience measure (Hemo-TEM) total score
Device handling experience using the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire
FRONTIER 5 Trial Design
1Treatment groups
Experimental Treatment
Group I: NNC0365-3769 (Mim8) PPXExperimental Treatment1 Intervention
Participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector.
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Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,415,020 Total Patients Enrolled
98 Trials studying Hemophilia A
10,457 Patients Enrolled for Hemophilia A
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,778 Total Patients Enrolled
4 Trials studying Hemophilia A
632 Patients Enrolled for Hemophilia A
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver tests are significantly higher than normal.I have surgery planned within the next 6 months.I have received FVIII gene therapy before.I choose to stop emicizumab and switch to Mim8 for 26 weeks.I do not have any health issues that could affect my safety or ability to follow the study plan.I have had or am at risk for blood clots.I am undergoing or will undergo therapy to reduce my body's immune response.I am mentally capable and willing to follow study procedures.I have been diagnosed with congenital haemophilia A.I am 12 years old or older.I have been on emicizumab for at least 8 weeks.I am not pregnant, breastfeeding, planning to become pregnant, or if of childbearing potential, I am using effective contraception.My kidney function is severely reduced.I have a blood clotting disorder that is not haemophilia A.I (or my caregiver) can attend all visits and complete an electronic diary and questionnaires.
Research Study Groups:
This trial has the following groups:- Group 1: NNC0365-3769 (Mim8) PPX
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for those seeking to take part in this clinical trial?
"According to clinicaltrials.gov, the posting for this trial was first made on June 26th 2023 and last updated on May 12th of that same year. This study is no longer actively looking for participants; however, there are 95 other trials currently recruiting volunteers."
Answered by AI
Are there any Canadian study sites currently conducting the research?
"This clinical trial is currently being conducted at 27 distinct locations, including Aurora, Tampa and Iowa City. To reduce the burden of travel associated with enrollment, it's advisable to select the trial site closest to your home address."
Answered by AI
What potential risks does the use of NNC0365-3769 (Mim8) PPX present to individuals?
"Taking into account the Phase 3 status of NNC0365-3769 (Mim8) PPX, our team at Power has assigned it a score of 3 for safety as there is clinical evidence indicating both its efficacy and multiple rounds verifying its security."
Answered by AI
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