Active not recruitingPHASE3INTERVENTIONAL

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)

This research study, called FRONTIER 4, is looking at a new medicine called Mim8. It's for people who have haemophilia A, whether or not they have developed 'inhibitors' (antibodies that stop usual treatments from working). Mim8 helps blood to clot better, which aims to prevent bleeding episodes. The study will last for up to 5 and a half years, or until Mim8 becomes widely available in your country, or until June 2028, whichever comes first. Participants will receive injections of Mim8 and will need to attend regular appointments. This study is specifically designed for people who have already been taking part in other Mim8 studies.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

451

Start

13 Feb 2023

Estimated completion

30 Jun 2028

Haemophilia A Haemophilia A With Inhibitors

What is this study about?

This study, known as FRONTIER 4, is all about understanding how a new medicine called Mim8 works over a longer period in people with haemophilia A. Haemophilia A is a condition where your blood doesn't clot properly, leading to bleeding problems. Some people with haemophilia A also develop 'inhibitors,' which are like antibodies that stop their usual clotting factor medicine from working effectively. Mim8 is designed to help your blood clot, much like the missing Factor VIII does, to prevent these bleeding episodes.

The main goal is to see how well Mim8 works to stop bleeds and how safe it is when used as a long-term treatment. Because Mim8 is a new medicine, it's important to carefully study its effects over time. If Mim8 proves to be safe and effective, it could offer a new way for people with haemophilia A, including those with inhibitors, to manage their condition and reduce bleeding.

This particular study is for people who are already taking part in other Mim8 clinical trials. This helps researchers to track the effects of the medicine continuously and gather more information as people switch from one study to another. This ongoing research is crucial to bringing new, helpful treatments to people who need them.

Key takeaways

This study is testing a new haemophilia A medicine called Mim8.
It's for long-term use to prevent bleeding episodes.
Only open to people already in other Mim8 studies.
The study can last up to 5.5 years.
You will receive Mim8 through injections.

Who may be eligible?

To join this study, you must already be taking part in one of four specific Mim8 studies (NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) and meet certain conditions related to your participation in those studies. You also need to have been diagnosed with haemophilia A.

It's important that you, or your parent/guardian if you're under 18, are happy and able to come to all the scheduled appointments and follow the study instructions, including keeping a diary. If you're a woman, you cannot be pregnant, breastfeeding, or planning to become pregnant during the study period. If you could become pregnant, you'll need to use a reliable method of contraception.

You wouldn't be able to join if you have any other serious health issues that your doctor thinks might make it unsafe for you to participate, or if you've already been withdrawn from or left the previous Mim8 studies. Also, if you're taking part in another clinical study for a different medicine, or have major surgery planned soon, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with haemophilia A.
I am currently taking part in one of the specific Mim8 studies my doctor mentioned.
I am able and willing to attend all study visits and keep a diary.
I am not pregnant, breastfeeding, or planning to get pregnant (if applicable).

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be using the medicine Mim8 to help prevent bleeding episodes. The study could last between a few months and up to 5 and a half years, depending on when you started and if Mim8 becomes available in your country. You'll switch from your current Mim8 study to this one.

You will receive Mim8 as injections, and the total number of injections will depend on how long you are in the study and how often your doctor decides you need them. This could be up to 262 injections over the whole study period. You'll have regular visits with the study team to check your health, see how the medicine is working, and make sure you're doing okay. You might also need to keep a diary of your health and any bleeding events. Your study doctor will tell you about any other medicines you shouldn't take while in the study. If you do have a bleed, your doctor will discuss the best way to treat it.

Potential risks and benefits

Taking part in this study might offer the benefit of continuing to receive Mim8, which could help manage your haemophilia A and reduce bleeding. However, as with any new medicine, there could be side effects or risks that we don't fully know about yet. Your study doctor will explain all known risks. You can choose to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (140)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Children's Hospital Los Angeles - Endocrinology
Verified postcode
Los Angeles, United States
UC Denver Hemoph & Thrombo Ctr
Verified postcode
Aurora, United States
Univ of Miami/SCCC
Verified postcode
Miami, United States
St Joseph's Hospital Foundation
Verified postcode
Tampa, United States
Children's Healthcare Atlanta
Verified postcode
Atlanta, United States
Rush University Med. Cntr
Verified postcode
Chicago, United States
Rush University Medical Center
Verified postcode
Chicago, United States
Indiana Hemophilia-Thromb Ctr
Verified postcode
Indianapolis, United States
University of Iowa_Iowa City
Verified postcode
Iowa City, United States
Central Michigan University
Verified postcode
Detroit, United States
Univ Hosp Cleveland Med Ctr
Verified postcode
Cleveland, United States
Dayton Children Hemostati Ctr
Verified postcode
Dayton, United States

Common questions

What is Mim8?

Mim8 is a new medicine being studied to help people with haemophilia A prevent bleeding by helping their blood clot properly.

How long will I be in the study?

The study can last up to 5 and a half years, but it might end sooner if Mim8 is approved and available in your country, or by June 2028, whichever comes first.

Do I have to be in another study to join this one?

Yes, this study is only for people who are already taking part in one of the specific Mim8 research studies mentioned by your doctor.

Can women join this study?

Yes, both men and women can join. However, women cannot be pregnant, breastfeeding, or planning to get pregnant during the study. If you could become pregnant, you'll need to use reliable contraception.

What happens if I have a bleed during the study?

If you have a bleed, your study doctor will work with you to decide on the best extra medicines to treat it.