HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac
function, improves microcirculation, and increases blood pressure and pulse pressure, and
improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined
multiple target pharmacological effects.
Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock
patient.
This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin
Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with
traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with
systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure
stabilization, regardless the types of completed, on-going, or projected Standard of Care or
surgery will be recruited to participant in the trial. A total of 120 patients with
traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each
type of shock, sixty patients each will be in test group and control group. Both adult males
and females aged 18-80 years are eligible. The primary clinical endpoint is the time length
(TL) between the start of HW6 administration to the onset of the first treatment success,
that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour
without the use of vasopressors. Several secondary endpoints and biomarkers will be measured.
Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment
groups and placebo groups. Safety data will also be reported accordingly.