Clinical trial NCT01780129: Polydatin Injectable (HW6) for Shock Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Shock, Hemorrhagic
Shock, Traumatic
Shock, Septic
Lead sponsor: Neptunus Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The time length (TL) between the start of HW6 administration to the onset of the first TS.
timeFrame: From the start of drug administration to the onset of TS (OTS) where the first systolic blood pressure≥90mmHg and MAP≥65mmHg is observed in the 7 consecutive measures
Secondary outcomes:
measure: The amount and duration of total vasopressor(s) used during this TL period
timeFrame: From the start of drug administration to the onset of TS (OTS) where the first systolic blood pressure≥90mmHg and MAP≥65mmHg is observed in the 7 consecutive measures
measure: The degree of fluid dependence
timeFrame: from the start of testing drug to the OTS
measure: Metabolic indicators
timeFrame: Within 6 days
measure: Severity of organ dysfunction in the ICU
timeFrame: Daily during the administration stay after enrollment
measure: Duration of ICU stay
timeFrame: The total time (in hours) of ICU admission from the day of administration to day 7 (7 days)
measure: 28-day survival
timeFrame: From the end of drug administration to Day 28
Other outcomes:
measure: Fluid intake and output volume
timeFrame: Every 24h for 5 days
Locations:
city: Newark
country: United States
facility: Christiana Care
state: Delaware
Study officials:
affiliation: Neptunus Pharmaceuticals Inc.
name: YU Lin, PhD
role: STUDY_CHAIR
References: