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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00531479 | Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis | PHASE3 | COMPLETED | 459 | — | — | Jul 1, 2008 | May 1, 2011 | Apr 30, 2012 | 107 | United States, Australia +22 |
| NCT00037206 | A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA). | PHASE2 | COMPLETED | 30 | — | — | May 1, 2002 | Feb 1, 2003 | Oct 21, 2008 | 1 | United States |
Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
| Arm | Type | Description |
|---|---|---|
| Voriconazole | ACTIVE_COMPARATOR | Voriconazole monotherapy |
| Voriconazole and Anidulafungin | EXPERIMENTAL | Combination therapy with voriconazole and anidulafungin |
| Name | Type | Description |
|---|---|---|
| voriconazole | DRUG | First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. |
| anidulafungin | DRUG | First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. |
| Anidulafungin, VER002 | DRUG | - |
Inclusion Criteria: * Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy; * Diagnosis of possible, probable, or proven invasive aspergillosis. Exclusion Criteria: * Patients with aspergilloma or chronic aspergillosis * Receipt ...