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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06812390 | Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites | PHASE2 | RECRUITING | 20 | — | — | Feb 28, 2025 | Mar 1, 2027 | Mar 11, 2025 | 1 | United States |
| NCT06052176 | Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement | PHASE2 | RECRUITING | 30 | — | — | Nov 2, 2023 | Dec 1, 2026 | Apr 8, 2026 | 1 | United States |
Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo
cognitive improvement (PHES score ranges from -15 to 5), higher is good
| Arm | Type | Description |
|---|---|---|
| Albumin first | ACTIVE_COMPARATOR | Albumin for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive placebo for one dose. |
| Placebo first | PLACEBO_COMPARATOR | Placebo for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose. |
| Placebo | PLACEBO_COMPARATOR | Saline given at the same volume as the albumin on visits the patients are assigned to it |
| Albumin | ACTIVE_COMPARATOR | IV Albumin at 1.5g/kg ideal body weight |
| Name | Type | Description |
|---|---|---|
| Albumin infusion (25% albumin) | DRUG | Albumin 25 gram infusion |
| Normal Saline (0.9% NaCl) | DRUG | 100 cc of normal saline |
| Albumin Infusion | DRUG | Intravenous human serum albumin to be given at 1.5g/kg ideal body weight |
Inclusion Criteria: * Outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration * Serum albumin of \< 3.5 g/dL * Age \>=18 years old Exclusion Criteria: * Patients with GFR \< 30mL/min/1.73 m2 * Changes in or...