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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03515044 | Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) | PHASE2 | COMPLETED | 71 | — | — | Sep 13, 2018 | Mar 12, 2020 | Apr 13, 2023 | 34 | United States |
A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 40 mg Rifaximin SSD once daily | EXPERIMENTAL | 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose |
| Cohort 2 40 mg Rifaximin SSD twice daily | EXPERIMENTAL | 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose |
| Cohort 3 80 mg Rifaximin SSD once daily | EXPERIMENTAL | 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose |
| Cohort 4 80 mg Rifaximin SSD twice daiy | EXPERIMENTAL | 80 mg Rifaximin sustained extended release (SER) rifaximin SSD twice daily (BID) and lactulose |
| Cohort 5 Placebo twice daily | EXPERIMENTAL | SSD placebo twice daily (BID) and lactulose |
| Name | Type | Description |
|---|---|---|
| 40 mg Rifaximin SSD once daily | DRUG | SSD once daily (QD) |
| 40 mg Rifaximin SSD twice daily | DRUG | SSD twice daily (BID) |
| 80 mg Rifaximin SSD once daily | DRUG | SSD once daily (QD) |
| 80 mg Rifaximin SSD twice daily | DRUG | SSD twice daily (BID) |
| Placebo | DRUG | Administered twice daily (BID) |
Inclusion Criteria: * Male or female age 18 to 75 years of age (inclusive) at the time of screening. * Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contracept...