Approval Probability
TA Base Rate
Adjusted LOA
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Terlipressin · 1 trial · 1 indication
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....
Terlipressin is an investigational small molecule being studied for use in compensated cirrhosis and portal hypertension. It is a vasoactive agent that has been evaluated in a Phase 2 clinical trial to explore its haemodynamic effects in patients with these conditions. The drug is not yet approved and remains in clinical development.
Terlipressin is a vasopressin analogue that acts on V1 receptors to cause vasoconstriction of splanchnic vessels, thereby reducing portal blood flow and portal pressure. This mechanism is relevant in portal hypertension associated with cirrhosis. The drug's target is the V1 receptor, which mediates its haemodynamic effects.
Terlipressin is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical research on this drug for the treatment of compensated cirrhosis and portal hypertension.
Terlipressin is in Phase 2 clinical development. It has completed a Phase 2 trial, and it is not yet approved by regulatory authorities. The drug remains investigational and is being evaluated for its safety and efficacy in patients with compensated cirrhosis and portal hypertension.
Terlipressin has been studied in one completed Phase 2 clinical trial with the identifier NCT01640964. This trial was an exploratory haemodynamic study in patients with compensated cirrhosis and portal hypertension, conducted in the United Kingdom with 47 participants. The study was randomized and controlled.
Terlipressin is a synthetic analogue of vasopressin, a naturally occurring hormone. While related, they are distinct compounds. Terlipressin has a longer duration of action and greater selectivity for V1 receptors compared to vasopressin. It is being developed for portal hypertension in cirrhosis.