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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01232595 | Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections | PHASE2 | COMPLETED | 109 | — | — | Oct 1, 2010 | Jul 1, 2013 | Dec 19, 2020 | 18 | United States, Canada |
Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events. (Cohorts 1 and 2)
Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and \<3 non-lliquid stools per day for two consecutive days
Clinical cure is resolution or improvement of symptoms and signs of C. difficile infection such that additional or alternative antimicrobial therapy or other theraperutic intervention is not needed. In addition, patient must have absence of fever for two consecutive days and \<3 non-lliquid stools per day for two consecutive days.
Safety assessments will include vital signs, laboratory tests, electrocardiograms (ECG), pharmacokinetic (PK) samples and adverse events.
| Arm | Type | Description |
|---|---|---|
| LFF571 (POC) | EXPERIMENTAL | - |
| Vancomycin (POC) | ACTIVE_COMPARATOR | - |
| LFF571 Dose level 1 (cohort 2) | EXPERIMENTAL | - |
| LFF571 Dose level 2 (cohort 2) | EXPERIMENTAL | - |
| LFF571 Dose level 3 (cohort 2) | EXPERIMENTAL | - |
| LFF571 Dose level 4 (cohort 2) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LFF571 | DRUG | - |
| Vancomycin (POC) | DRUG | - |
Inclusion Criteria: * Males and females between 18 and 90 years of age, inclusive. * Diagnosed with primary episode or first relapse of moderate C. difficile infection. Received ≤24 hours of therapy effective for C. difficile infection prior to enrollment. Exclusion Criteria: * Severe C. diffici...