Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Angiotensin II · 2 trials · 6 indications
Calculated as the sum of all NE doses (in mcg) administered by either infusion or bolus during LT surgery, divided by the subjects total body weight (TBW, in kg), divided by the duration of surgery (in min). The Primary Outcome will be expressed in mcg/kg/min.
To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).
To evaluate the effect of LJPC-501 in the reduction of the sum norepinephrine (NE) equivalent dosing.
| Arm | Type | Description |
|---|---|---|
| Angiotensin II (Giapreza) | EXPERIMENTAL | Giapreza (synthetic human angiotensin II), initiated at 5 ng/kg/min and titrated to between 1.25 ng/kg/min and 40 ng/kg/min, administered by continuous intravenous infusion. |
| Saline | PLACEBO_COMPARATOR | Sterile 0.9% saline, initiated and titrated at an equivalent volume infusion rate to the study drug, administered by continuous intravenous infusion. |
| LJPC-501 | EXPERIMENTAL | Angiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours. |
| Name | Type | Description |
|---|---|---|
| Angiotensin II | DRUG | Infusion of Angiotensin II initiated if participants require norepinephrine at a rate of \> 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete. |
| Saline | DRUG | Infusion of 0.9% saline initiated if participants require norepinephrine at a rate of \> 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete. |
Inclusion Criteria: * Age \> or = 18 years * Liver transplantation from a deceased donor * Model for End-stage Liver Disease Sodium (MELD-Na) score \> or = 25 at the time of transplant (not counting MELD exception points) * Patient requiring \> 0.05 mcg/kg/min of norepinephrine (NE) during LT Excl...
Angiotensin II is an investigational small molecule being studied for catecholamine-resistant hypotension (CRH) and complications in liver transplant, including vasoplegia. It is in Phase 2 clinical development and is not approved by the FDA.
Angiotensin II is a synthetic form of the naturally occurring hormone angiotensin II, which acts on angiotensin receptors to cause vasoconstriction and raise blood pressure. It is being studied to treat hypotension that does not respond to catecholamines.
Angiotensin II is being developed by Innoviva, Inc., a biopharmaceutical company traded on NASDAQ under the ticker INVA.
Angiotensin II is in Phase 2 clinical development. It is being studied in two trials: one completed trial in pediatric patients with catecholamine-resistant hypotension and one active trial in liver transplant patients with vasoplegia.
Angiotensin II is being studied in two Phase 2 trials. NCT03431077, a completed study in pediatric patients with catecholamine-resistant hypotension, and NCT04901169, an active trial in liver transplant patients with vasoplegia. The active trial has an enrollment of 50 participants.
Yes, Angiotensin II is also known as LJPC-501. The completed pediatric trial NCT03431077 refers to the drug as LJPC-501, while the liver transplant trial uses the name Angiotensin II.