Title
Polydatin Injectable (HW6) for Shock Treatment
A Randomized, Double-Blind, Placebo Controlled, Parallel Group Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HW6 in the Treatment of Traumatic/Hemorrhagic Shock and Septic Shock
Phase
Phase 2Lead Sponsor
Neptunus Pharmaceuticals Inc.Study Type
InterventionalStatus
Unknown statusIndication/Condition
Shock, Hemorrhagic Shock, Traumatic Shock, SepticIntervention/Treatment
polydotin ...Study Participants
240HW6 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.
Dilute two 100mg/5mL vials of HW6 into 500mL 0.9% NaCl injection and administer as i.v. infusion over 2 hours. The drug should be given as early as possible right after the IC Form is signed on Day 1, and once every 24 hours for additional 4 doses.
10ml(2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days
10ml (2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days
Inclusion Criteria: Adult males or females aged 18-80 years. 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, ongoing, or projected Standard of Care or surgery. Patients (or its relative) who have signed Informed Consent Form to voluntarily participate in this clinical study. Exclusion Criteria: Has known allergic constitution or history of alcohol or drug allergy. or Complicating acute cardiac failure, acute renal failure, acute liver failure or disseminated intravascular coagulation (DIC). or Pregnant or lactating women. or Complicating moderate to severe craniocerebral injury. or Has known previous severe chronic disease(s) in liver, kidney, carvascualr system or central nervous system. or
