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

Not Applicable

Active, not recruiting

Conditions: Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

Registration Number: KCT0008901

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 29

Inclusion Criteria

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 4513, 4514, 4516, or 4728 at the time of transfer. Participant
should qualify either of the following criteria:
a. Participant from study 4513, who has participated in the extension part of the study for at
least 12 weeks prior to enrolment in study 4532, or,
b. Participant has completed the end of treatment visit for study 4514,4516, or 4728.
4. Participant and/or participant’s parent(s)/participant’s LAR willingness and ability to comply
with scheduled visits and study procedures, including the completion of diary.

Exclusion Criteria

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 Participant who has discontinued or been withdrawn from studies 4513, 4514, 4516, or 4728.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 other interventional clinical study (except from study 4513, 4514, 4516, or 4728) of an approved or non-approved investigational medicinal product.
7. Any planned major surgery, during part 1 of the study. For definition of major surgery see (Table 6-7).
8. Mental incapacity, unwillingness

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
umber of treated bleeding episodes;Number of treated spontaneous bleeding episodes;Number of treated traumatic bleeding episodes;Number of treated joint bleeding episodes;Number of treated target joint bleeding episodes (Arm 2);Mim8 plasma concentration;Device handling experience using Haemophilia Device Assessment Tool (HDAT) (applicable for participants in Arm 2 only).