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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02246595 | Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction | PHASE2 | COMPLETED | 72 | — | — | Apr 1, 2014 | Dec 1, 2015 | Apr 25, 2016 | 11 | Germany |
Pharmacokinetic measures include * Plasma concentration over time * Maximum observed concentration per infusion * Concentration measured immediately before next dosing * Area under the curve of plasma concentration per infusion * Mean concentration per infusion * Terminal phase half-life
| Arm | Type | Description |
|---|---|---|
| CaCP29 | ACTIVE_COMPARATOR | dose escalating i.v. administration of CaCP29 (verum) |
| Placebo | PLACEBO_COMPARATOR | dose escalation mimicing i.v. placebo treatment: |
| Name | Type | Description |
|---|---|---|
| CaCP29 | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Key Inclusion Criteria at screening: 1. Male or female patients \>= 18 years old 2. Written informed consent 3. Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS) not explained by other reasons. These criteria should be present within 12 hours prior to screening...