Polydatin Injectable (HW6) for Shock Treatment
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | February 2013 |
| End Date: | December 2014 |
| Contact: | SUN Henry, PHD |
| Email: | henrysun@neptunus.com |
| Phone: | (301) 956-9607 |
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
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.
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.
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
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