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Polydatin Injectable (HW6) for Shock Treatment (PIST)

This study is not yet open for participant recruitment.
Verified January 2013 by Neptunus Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
Neptunus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01780129
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Shock, Hemorrhagic
Shock, Traumatic
Shock, Septic
Drug: Polydatin Injectable
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Neptunus Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Metabolic indicators [ Time Frame: Within 6 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 28-day survival [ Time Frame: From the end of drug administration to Day 28 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Fluid intake and output volume [ Time Frame: Every 24h for 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780129

Contacts
Contact: SUN Henry, PHD (301) 956-9607 henrysun@neptunus.com

Locations
United States, Delaware
Christiana Care Not yet recruiting
Newark, Delaware, United States, 19718
Contact: GERARD FULDA, PhD    302-733-4260    gfulda@christianacare.org   
Principal Investigator: GERARD FULDA, PhD         
Sponsors and Collaborators
Neptunus Pharmaceuticals Inc.
Investigators
Study Chair: YU Lin, PhD Neptunus Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Neptunus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01780129     History of Changes
Other Study ID Numbers: HW6-01-US, HW6-01-US
Study First Received: January 29, 2013
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Shock
Shock, Hemorrhagic
Shock, Septic
Shock, Traumatic
Pathologic Processes
Hemorrhage
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014