Shock, HemorrhagicPhase 2PISTNCT01780129
Polydatin Injectable (HW6) for Shock Treatment
A Phase 2 study testing Polydatin Injectable in people with Shock, Hemorrhagic and Shock, Traumatic, run by Neptunus Pharmaceuticals Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shock, Hemorrhagic, Shock, Traumatic, Shock, Septic
- What is being tested?
- Polydatin Injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care
Newark, Delaware, 19718
GERARD FULDA, PhD, 302-733-4260, gfulda@christianacare.org
GERARD FULDA, PhD
About this study
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
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.
Read more
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
- Being tested
- Polydatin Injectable
- Medical subject headings
- Shock, Hemorrhagic, Shock, Traumatic, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polydatin InjectableDrug
Also called HW6
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: from the start of testing drug to the OTS
Metabolic indicators
Arterial blood lactate, lactate clearance, oxygen saturation mixed venous blood, blood gas levels
Measured: Within 6 days
Severity of organ dysfunction in the ICU
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.
Measured: Daily during the administration stay after enrollment
Duration of ICU stay
Measured: The total time (in hours) of ICU admission from the day of administration to day 7 (7 days)
28-day survival
Measured: From the end of drug administration to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, HemorrhagicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neptunus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YU Lin, PhD, Study chair, Neptunus Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780129
- Sponsor's protocol ID
- HW6-01-US
- Other IDs
- HW6-01-US
- Acronym
- PIST
- Status last verified
- Jan 2013
- First submitted
- 29 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01780129
- Acronym / sponsor ID
- PIST / HW6-01-US
- Conditions
- Shock, Hemorrhagic, Shock, Traumatic, Shock, Septic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Neptunus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polydatin Injectable (HW6) | Experimental | Drug: Polydatin Injectable10ml(2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days |
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polydatin InjectableAlso: HW6Dilute 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. | Drug | Polydatin Injectable (HW6) |
Primary outcome
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.
6 secondary outcomes
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
The degree of fluid dependence
Time frame: from the start of testing drug to the OTS
Metabolic indicators
Time frame: Within 6 days
Severity of organ dysfunction in the ICU
Time frame: Daily during the administration stay after enrollment
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YU Lin, PhD study chair
Neptunus Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polydatin Injectable in people with Shock, Hemorrhagic and Shock, Traumatic, run by Neptunus Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SUN Henry, PHD ((301) 956-9607, henrysun@neptunus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.