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Replacement Therapy
Mim8 for Hemophilia A (FRONTIER4 Trial)
Phase 3
Recruiting
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 8 (week 26) until end of treatment (up to 262 weeks)
Awards & highlights
FRONTIER4 Trial 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.
Who is the study for?
This trial is for males and females with congenital haemophilia A who are already participating in certain ongoing Mim8 studies. They must be able to follow the study schedule and procedures, including diary completion. Pregnant or breastfeeding women, those planning pregnancy, or not using effective contraception are excluded.Check my eligibility
What is being tested?
The trial tests long-term use of Mim8, a new medication designed to prevent bleeding in people with haemophilia A by mimicking clotting factor VIII. Participants will receive up to 262 subcutaneous injections over a maximum of 5.5 years or until Mim8 becomes commercially available.See study design
What are the potential side effects?
While specific side effects for Mim8 aren't listed here, similar treatments may cause injection site reactions, potential development of inhibitors (antibodies against the treatment), allergic reactions, and could potentially affect other medications.
FRONTIER4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from visit 8 (week 26) until end of treatment (up to 262 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from visit 8 (week 26) until end of treatment (up to 262 weeks)
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
Device handling using haemophilia device assessment tool (HDAT) (applicable for participants in arm 2 only)
Mim8 plasma concentration
Number of injection site reactions
+6 moreFRONTIER4 Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
Participants entering from study NN7769-4514 or NN7769-4516. In part 1, participants will receive Mim8 PPX QW or QM with s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX QW, Q2W or QM with s.c. administration using DV3407 pen-injector.
Group II: Arm 1Experimental Treatment1 Intervention
Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) once every two weeks (Q2W) with subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX once-weekly (QW), Q2W or once-monthly (QM) with s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved.
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Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,643 Total Patients Enrolled
1 Trials studying Hemophilia
100 Patients Enrolled for Hemophilia
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,581 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with congenital haemophilia A.I have no major surgeries planned during the early phase of the study.I am not pregnant, breastfeeding, nor planning to become pregnant.I am a woman who can have children and am not using effective birth control.I am mentally capable and willing to follow study procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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