A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNovo Nordisk A/S
About this trial
This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in June 2028, whichever comes first. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections and how long time participants take part in the study. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Male or female with diagnosis of congenital haemophilia A based on medical records.
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,
Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728.
Disqualifiers
Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728.
Previous participation in this study. Participation is defined as signed informed consent.
Female who is pregnant, breast-feeding or intends to become pregnant.
Trial design
Design model
Parallel
Treatments tested in this trial
Mim8
DrugParticipants in arm 1 will administer Mim8 using an enhanced cartridge and switch to the DV3407 pen-injector once it is approved. Participants in arm 2 and 3 will use the DV3407 pen injector.
Treatment groups
451 Participants
are divided into 3 treatment groupsGroup A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Arm 1 and 2: Number of treatment emergent adverse events
Measured as count of events.
Time frame
From week 0 until end of study (up to 283 weeks)2
Arm 3: Number of treatment emergent adverse events
Measured as count of events.
Time frame
From treatment initiation (week 0) until end of study (up to 124 weeks)Secondary outcomes
1
Arm 1 and 2: Number of injection site reactions
Measured as count of reactions.
Time frame
From week 0 until end of treatment (up to 262 weeks)2
Arm 1 and 2: Occurrence of anti Mim8 antibodies
Measured as count of participants.
Time frame
From week 0 until end of treatment (up to 262 weeks)3
Arm 1 and 2: Number of treated bleeding episodes
Measured as count of bleeds.
Time frame
From week 0 until end of treatment (up to 262 weeks)4
Arm 1 and 2: Number of treated spontaneous bleeding episodes
Measured as count of bleeds.
Time frame
From week 0 until end of treatment (up to 262 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov