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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02380924 | Recovery and Survival of EryDex in Non-patient Volunteers | PHASE1 | COMPLETED | 10 | — | — | Jan 1, 2015 | Jun 1, 2015 | Feb 1, 2016 | 1 | United States |
The 24-hour recovery of autologous RBCs loaded with DSP or sham using the EDS will be greater than 75% with 95% confidence. For RBC kinetics and recovery will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
For RBC T50 will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
| Arm | Type | Description |
|---|---|---|
| DSP loaded RBC using EryDex System | ACTIVE_COMPARATOR | Autologous RBC loaded with DSP using the EDS process, and treated RBC are infused to the subject. |
| Sham treated RBC using the EryDex System | SHAM_COMPARATOR | Autologous RBC are treated with buffer using the EDS process, and treated RBC are infused to the subject. |
| Name | Type | Description |
|---|---|---|
| DSP loaded RBC using EryDex System | DRUG | Intravenous infusion of 10 mg DSP encapsulated in autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC. |
| Sham treated RBC using the EryDex System | DRUG | Intravenous infusion of sham treated autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC. |
Inclusion Criteria: * If female of childbearing potential\*, the subject agrees not to donate ova and to use one of 4 methods of contraception from the time of signing the informed consent until 2 months after infusion * If male, the subject agrees to not donate sperm and to use barrier contracepti...