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Polydatin Injectable (HW6) for Shock Treatment (PIST)

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ClinicalTrials.gov Identifier: NCT01780129
Recruitment Status : Unknown
Verified January 2013 by Neptunus Pharmaceuticals Inc..
Recruitment status was:  Not yet recruiting
First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
Neptunus Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE January 29, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date January 30, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
The time length (TL) between the start of HW6 administration to the onset of the first TS. [ Time Frame: 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 ]
Treatment success (TS): the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour without the use of vasopressor(s). Blood pressure will be recorded every 10 min. Treatment success is considered to have been achieved when 7 consecutive systolic blood pressure to be≥90mmHg and MAP≥65mmHg. The TL is the time 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. Blood pressure will be measured every hour after the TS. If blood pressure become unstable, standard care will be in practice.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
  • The amount and duration of total vasopressor(s) used during this TL period [ Time Frame: 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 ]
    Observation period: From start of study drug treatment to OTS. Record the details of the use of vasopressor(s) during TL for each subject, including name of medication, infusion concentration and rate, and the duration of each concentration and rate being maintained. Duration of vasopressor(s) use: accurate to the minute, or by the cumulative time of each administration if used intermittently. Total dose of vasopressor(s):The total dose of each vasopressor.
  • The degree of fluid dependence [ Time Frame: from the start of testing drug to the OTS ]
  • Metabolic indicators [ Time Frame: Within 6 days ]
    Arterial blood lactate, lactate clearance, oxygen saturation mixed venous blood, blood gas levels
  • Severity of organ dysfunction in the ICU [ Time Frame: Daily during the administration stay after enrollment ]
    Compare the changes in SOFA score during the administration stay between the two groups to assess the protective effect of the study drug on vital organs.
  • Duration of ICU stay [ Time Frame: The total time (in hours) of ICU admission from the day of administration to day 7 (7 days) ]
  • 28-day survival [ Time Frame: From the end of drug administration to Day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 29, 2013)
Fluid intake and output volume [ Time Frame: Every 24h for 5 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Polydatin Injectable (HW6) for Shock Treatment
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Shock, Hemorrhagic
  • Shock, Traumatic
  • Shock, Septic
Intervention  ICMJE Drug: Polydatin Injectable
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.
Other Name: HW6
Study Arms  ICMJE
  • Experimental: Polydatin Injectable (HW6)
    10ml(2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days
    Intervention: Drug: Polydatin Injectable
  • Placebo Comparator: HW6 blank dummy (0.9%NaCl)
    10ml (2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 29, 2013)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01780129
Other Study ID Numbers  ICMJE HW6-01-US
HW6-01-US ( Registry Identifier: Neptunus Pharmaceuticals, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neptunus Pharmaceuticals Inc.
Study Sponsor  ICMJE Neptunus Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: YU Lin, PhD Neptunus Pharmaceuticals Inc.
PRS Account Neptunus Pharmaceuticals Inc.
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP