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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01145560 | A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock | PHASE2 | COMPLETED | 300 | — | — | Oct 1, 2010 | May 1, 2012 | Oct 6, 2014 | 52 | Australia, Belgium +5 |
| NCT01144624 | A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock | PHASE2 | COMPLETED | 20 | — | — | Jul 1, 2010 | Aug 1, 2011 | Oct 6, 2014 | 7 | Japan |
| NCT00615017 | AZD9773 Dose Escalation Study | PHASE2 | COMPLETED | 70 | — | — | Jan 1, 2008 | Jul 1, 2009 | Aug 22, 2013 | 26 | United States |
Number of ventilator-free days (VFDs)
Number of patients with treatment-emergent adverse events and number of patients who died over 28 days
Maximum concentration at steady state (Cmax ss) for serum total and specific fabs
Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in prothrombin time values from baseline (pre-infusion) to Day 7 \[calculated as Day 7 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in troponin I values from baseline (pre-infusion) to Day 6 \[calculated as Day 6 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 \[calculated as Day 1 mean minus baseline mean\] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo \[calculated as Day 5 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 \[calculated as Day 14 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in body weight from baseline (pre-infusion) to Day 6 \[calculated as Day 6 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | AZD9773 250/50 units/kg |
| 2 | EXPERIMENTAL | AZD9773 500/100 units/kg |
| 3 | PLACEBO_COMPARATOR | - |
| AZD9773 cohort 1 (50 units/kg) | EXPERIMENTAL | AZD9773: single infusion of 50 units/kg |
| AZD9773 cohort 2 (250 units/kg) | EXPERIMENTAL | AZD9773: single infusion of 250 units/kg |
| AZD9773 cohort 3 (250/50 units/kg) | EXPERIMENTAL | AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs |
| AZD9773 cohort 4 (500/100 units/kg) | EXPERIMENTAL | AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs |
| AZD9773 cohort 5 (750/250 units/kg) | EXPERIMENTAL | AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD9773 | DRUG | A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days |
| Placebo | DRUG | Placebo |
| AZD9773 (CytoFab) | DRUG | intravenous infusions |
Inclusion Criteria: * Adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics. * At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells \[WBC\]...