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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03186677 | Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients | PHASE1 | COMPLETED | 11 | — | — | Jun 3, 2017 | Feb 22, 2019 | Nov 10, 2020 | 3 | South Korea |
The number of reported AEs (local/systemic/other) after IP administration was calculated by cohort.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Single intravenous administration of BeneFIX (75 IU/kg) with 72 hours of observation, followed by single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation |
| Cohort 2 | EXPERIMENTAL | Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation |
| Cohort 3 | EXPERIMENTAL | Single intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) with 72 hours of observation, followed by single subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) with 120 hours of observation |
| Cohort 4 | EXPERIMENTAL | One subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) per day for 6 days with 240 hours of observation |
| Cohort 5 | EXPERIMENTAL | One intravenous administration of ISU304/CB2679d/Dalcinonacog alfa (75 IU/kg) followed by subcutaneous administration of ISU304/CB2679d/Dalcinonacog alfa (150 IU/kg) once daily for 9 days with 312 hours of observation |
| Name | Type | Description |
|---|---|---|
| ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg | BIOLOGICAL | ISU304/CB2679d/Dalcinonacog alfa 75\~150 IU/kg by intravenous or subcutaneous |
| BeneFIX | BIOLOGICAL | BeneFIX 75 IU/kg, intravenous administration |
Inclusion Criteria: 1. Previously treated male patients with moderate or severe hemophilia B (documented FIX activity ≤ 2% and exposed to any FIX product for ≥ 150 exposure days (estimated) at the time of screening) 2. Patients must be 12 to 65 years old at the time of screening 3. Patients who hav...