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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01640964 | An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension | PHASE2 | COMPLETED | 47 | — | — | Apr 1, 2013 | Dec 1, 2014 | Mar 15, 2016 | 1 | United Kingdom |
The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)
Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP). Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).
| Arm | Type | Description |
|---|---|---|
| Part A: Terlipressin acetate | EXPERIMENTAL | Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection. |
| Part A: Serelaxin (RLX030) | EXPERIMENTAL | Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition |
| Part B Serelaxin (RLX030) | EXPERIMENTAL | The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of Portal pressure gradient (PPG) data acquisition. |
| Name | Type | Description |
|---|---|---|
| Terlipressin acetate | DRUG | IV bolus injection |
| Serelaxin (RLX030) | DRUG | Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours |
Inclusion Criteria: Study Parts A and B: -Cirrhosis of alcohol aetiology according to physician's assessment prior to screening. Part A: -Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices). Part B: * Cirrhosis with TIPSS in situ and PPG\>5mmHg....