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Open-label, long-term safety and efficacy study of Mim8 in participants with haemophilia A with or without inhibitors(NN7769-4532) (FRONTIER 4)

A research study looking at long-term treatment with Mim8 in people with haemophilia A(NN7769-4532) (FRONTIER 4)

Esaki Risa

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

jphc_clinical_trials@novonordisk.com

Esaki Risa

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

+81-362661000

jphc_clinical_trials@novonordisk.com

Recruiting

Feb. 13, 2023

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1.Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2.Male or female with diagnosis of congenital haemophilia A based on medical records.
3.Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769 4728 at the time of transfer. Participant should qualify either of the following criteria:
a.Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or,
b.Participant has completed the end of treatment visit for study NN7769-4514, NN7769 4516, or NN7769-4728.
4.Participant and/or participant's parent(s)/participant's legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary.

1.Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
2.Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728.
3.Previous participation in this study. Participation is defined as signed informed consent.
4.Female who is pregnant, breast-feeding or intends to become pregnant.
5.Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures as defined in Appendix 4 or as required by local regulation or practice).
6.Participation (i.e., signed informed consent) in any interventional, clinical study (except from study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) of an approved or non-approved investigational medicinal product.
7. Any planned majors surgery, during part1 of the study, For definition of major surgery see Table6-7.
8.Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.

Both

Participants with haemophilia A with or without FVIII inhibitors

The study consists of two arms (Arms 1 and 2), where participants from study NN7769-4513 will enter Arm 1 and participants from studies NN7769-4514, NN7769 4516, and NN7769 4728 will enter Arm 2.

Treatment period is consistent of part1 and part2.
During part1(first 26 weeks of the study), participants transferring from study NN7769-4513 will all receive Q2W dosing. Participants transferring from study NN7769-4514, NN7769-4516, and NN7769-4728 will use the same treatment frequency as in their previous study (QW, Q2W, or QM).
After part1, during part2 study participants in both arms will get the choice to switch to another treatment frequency (QW, Q2W, or QM)

Dose amount is based on weight band of participant.
Weight bands and corresponding doses for study
Once-Weekly:
1.6mg(below15kg), 4.0mg(15kg or above, below 45kg), 9.0mg(45kg or above)

Once-Monthly
9.0mg(below 15kg), 20.0mg(15kg or above, below 45kg), 46.0mg(45kg or above)

Number of treatment-emergent adverse events (TEAEs)

+81-52-744-1958

Dec. 23, 2022

Yes

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Austria/Belgium/Bulgaria/Canada/China/Denmark/France/Germany/India/Ireland/Israel/Italy/Latvia/Lithuania/Malaysia/Mexico/Netherlands/Poland,/Portugal/Romania/Saudi Arabia/Serbia/Slovakia/South Africa/South Korea/Spain/Switzerland/Taiwan/Turkey/United Kingdom