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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01904409 | Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis | PHASE2 | COMPLETED | 420 | — | — | Jun 1, 2013 | Jul 1, 2015 | Oct 23, 2019 | 120 | United States, Russia |
The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo tablets once daily. |
| Rifaximin SSD 40 mg IR tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 40 mg immediate release (IR) tablet once daily. |
| Rifaximin SSD 80 mg IR tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet once daily. |
| Rifaximin SSD 40 mg SER tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 40 mg sustained extended release (SER) tablet once daily. |
| Rifaximin SSD 80 mg SER tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 80 mg sustained extended release(SER) tablet once daily. |
| Rifaximin SSD 80mgIR/80mgSER tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet + rifaximin SSD 80 mg sustained extended release (SER) tablet once daily. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| Rifaximin SSD 40 mg IR tablet | DRUG | - |
| Rifaximin SSD 80 mg IR tablet | DRUG | - |
| Rifaximin SSD 40 mg SER tablet | DRUG | - |
| Rifaximin SSD 80 mg SER tablet | DRUG | - |
| Rifaximin SSD 80mgIR/80mgSER tablet | DRUG | - |
Inclusion Criteria: * Diagnosis of liver cirrhosis and documented ascites. * Model End Stage Liver Disease (MELD) score of at least 12, MELD Na of at least 12, or Child-Pugh B (score of 7 - 9). * If applicable, has a close family or other personal contacts who can provide continuing oversight to th...