Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication 1. INDICATIONS AND USAGE GIAPREZA increases blood pressure in adults with septic or other distributive shock [see Clinical Studies (14)] . GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. ( 1 ) FDA label
Also known as Giapreza (synthetic human angiotensin II), Giapreza
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 yet approved by the FDA.
Angiotensin II targets the AT1R receptor. It is being evaluated for its potential role in managing blood pressure in conditions like catecholamine-resistant hypotension and liver transplant complications.
Angiotensin II is being developed by Innoviva, Inc., a company traded under the ticker INVA. The drug is currently in Phase 2 clinical trials for catecholamine-resistant hypotension and liver transplant complications.
Angiotensin II is in Phase 2 clinical development. It is being studied in active clinical trials for liver transplant complications and has completed a trial in pediatric patients with hypotension. It remains investigational and is not FDA approved.
Angiotensin II is being studied in NCT04901169, a Phase 2 trial in liver transplant complications and vasoplegia, which is active but not recruiting. Another trial, NCT03431077, in pediatric hypotension, has been completed.
Yes, Angiotensin II is also known as LJPC-501. The completed trial NCT03431077, which studied the drug in pediatric patients with hypotension, used the name LJPC-501 for the same compound.