Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as angiotensin II
LJPC-501 · 3 trials · 6 indications
Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.
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 |
|---|---|---|
| LJPC-501 (angiotensin II) | EXPERIMENTAL | Treatment arm |
| Placebo (0.9% sodium chloride solution) | PLACEBO_COMPARATOR | Placebo arm |
| 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 |
|---|---|---|
| LJPC-501 | DRUG | Treatment arm |
| Placebo | DRUG | PBO |
| 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: 1. Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of \> 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg. 2. Patients are required to have central venous access and an ...
LJPC-501 is being developed for catecholamine-resistant hypotension (CRH), a condition in which blood pressure remains dangerously low despite treatment with catecholamines. The clinical program has also studied patients with distributive shock, high output shock, and sepsis, which are the conditions listed in its Phase 3 trial.
LJPC-501 is being developed by Innoviva, Inc., which trades on the Nasdaq under the ticker INVA. Innoviva is the sponsor of the Phase 3 clinical program evaluating LJPC-501 in patients with catecholamine-resistant hypotension.
LJPC-501 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. LJPC-501 is an investigational small molecule and has not been approved by the FDA for any indication.
LJPC-501 has been evaluated in one Phase 3 trial, NCT02338843, titled A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension. That trial is completed and enrolled 344 patients across the United States, Australia, Belgium, Canada, Finland, France, Germany, New Zealand, Switzerland, and the United Kingdom.
The Phase 3 trial NCT02338843 was a randomized, double-blind, placebo-controlled study that enrolled 344 patients aged 18 years and older with catecholamine-resistant hypotension. It included patients with distributive shock, high output shock, and sepsis, and did not enroll healthy volunteers.