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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03107091 | Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites | PHASE2 | COMPLETED | 6 | — | — | Jul 15, 2017 | Apr 25, 2019 | Jul 13, 2021 | 1 | United States |
Rate of treatment emergent adverse events assessed by physical examination and laboratory safety
Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css)
| Arm | Type | Description |
|---|---|---|
| Terlipressin acetate continuous infusion | EXPERIMENTAL | Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days |
| Name | Type | Description |
|---|---|---|
| Terlipressin acetate continuous infusion | DRUG | Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days |
Inclusion Criteria: * Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days Exclusion Criteria: * Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carci...