Polydatin Injectable (HW6) for Shock Treatment

NCT01780129 | Unknown Phase 2 DMC

• 1 other identifier: HW6-01-US
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock, Hemorrhagic; Shock, Traumatic; Shock, Septic

Outcome Measures

Primary Outcomes (1)

• The time length (TL) between the start of HW6 administration to the onset of the first TS.

  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.

  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 (6)

• The amount and duration of total vasopressor(s) used during this TL period

  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

• The degree of fluid dependence

  from the start of testing drug to the OTS

• Metabolic indicators

  Within 6 days

• Severity of organ dysfunction in the ICU

  Daily during the administration stay after enrollment

• Duration of ICU stay

  The total time (in hours) of ICU admission from the day of administration to day 7 (7 days)

Other Outcomes (1)

• Fluid intake and output volume

  Every 24h for 5 days

Study Arms (2)

Polydatin Injectable (HW6)

EXPERIMENTAL

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

HW6 blank dummy (0.9%NaCl)

PLACEBO COMPARATOR

10ml (2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days

Interventions

Polydatin Injectable DRUG

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.

Also known as: HW6

Polydatin Injectable (HW6)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neptunus Pharmaceuticals Inc.: lead

Study Sites (1)

Christiana Care

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Shock, Hemorrhagic; Shock, Traumatic; Shock, Septic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Wounds and Injuries; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• YU Lin, PhD

  Neptunus Pharmaceuticals Inc.

  STUDY CHAIR

Central Study Contacts

SUN Henry, PHD

CONTACT

(301) 956-9607; henrysun@neptunus.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 30, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

US (1)