Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05685238 | A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4) | PHASE3 | ACTIVE NOT_RECRUITING | 451 | — | — | Feb 13, 2023 | Jun 30, 2028 | Apr 7, 2026 | 140 | United States, Austria +30 |
Measured as count of events.
Measured as count of events.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants entering from the multiple ascending dose (MAD) part of study NN7769-4513. In part 1, participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) administration using enhanced cartridge for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using enhanced cartridge or DV3407 pen-injector once it is approved. |
| Arm 2 | EXPERIMENTAL | Participants entering from study NN7769-4514, NN7769-4728 and NN7769-4516. In part 1, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector for 26 weeks. In part 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector. |
| Arm 3 | EXPERIMENTAL | In part 1 and 2, participants will receive Mim8 PPX s.c. administration using DV3407 pen-injector. |
| Name | Type | Description |
|---|---|---|
| Mim8 | DRUG | Participants 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. |
Arm 1 \& 2: 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 haemo...