The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)

April 19, 2018 updated by: Techpool Bio-Pharma Co., Ltd.

A Randomized, Blind, Placebo-controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)

Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After signed off the informed consent form by patient or surrogate, and after completing the screening phase, the patients who fulfill the inclusion and exclusion criteria will be randomized 1:1:1:1 to the 4 study arms. All the Patients will receive the study treatment drugs for 7 to 14 days. Use Day 28 of last patient as a cut-off day, Collect the follow up visit data on both Day 28 and Day 90 of other patients．

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
    • Beijing
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital, Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, China
        • First Affiliated Hospital of Guangzhou Medical University
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huadong Hospital,Fudan University
    • Shanghia
      • Shanghai, Shanghia, China, 200233
        • Shanghai sixth people's hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital,Sichuan Unversity
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310030
        • Zhejiang Hospital
      • Lishui, Zhejiang, China, 323000
        • Lishui City People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have provided signed written informed consent form (ICF) from the patient or the patient's legal representative;
  2. Male or Female patients ≥18 years of age;
  3. ARDS defined with using 2012 Berlin Criteria;
  4. ARDS diagnosed ≤7 days, and patients should be mechanically ventilated(invasive and or noninvasive mechanical ventilation); 5)100mmhg < PaO2/FiO2 < 250mmhg with CPAP/PEEP≥5 cmH2O;

Exclusion Criteria:

  1. Patient with known hypersensitivity to Ulinastatin/adjuvant or patient with allergic constitution;
  2. Patients with artificial organs replacement therapy for liver or kidney；
  3. Glasgow Coma Scale (GCS)≤8；
  4. Cardiogenic pulmonary edema , and the cardiogenic pulmonary edema is as the only or primary reason for respiratory failure;
  5. ARDS caused by burning, drowning, poisoning;
  6. Presence of severe chronic liver diseases (Child-Pugh score 12-15)，or severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen;
  7. Neutrophils<1.5×10^9/L
  8. Moribund patients (i.e.,expected to live no longer than 24 hours) or with recent (within 7days or anytime during present hospitalization) cardiopulmonary arrest;
  9. Patients need long-term glucocorticoid treatment or need to be treated with immunosuppressive drugs;
  10. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol;
  11. Lung transplant patients;
  12. Patients with malignancy, expected to live no longer than 6 months;
  13. Pregnant or breast-feeding;
  14. Patients who have participated in any clinical study within 3 months prior to the screening;
  15. Any condition that in the opinion of the investigator would add the patient's risk or jeopardize the operation of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Cohort 1- Ulinastatin 4.8 million units per day
Drug: ulinastatin
Patients will receive the study drugs for 7 to 14 days
Other Names:
  • UTI
  • urinary trypsin inhibitor
  • bikunin
Experimental: Cohort 2
Cohort 2- Ulinastatin 2.4 million units per day
Drug: ulinastatin
Patients will receive the study drugs for 7 to 14 days
Other Names:
  • UTI
  • urinary trypsin inhibitor
  • bikunin
Experimental: Cohort 3
Cohort 3- Ulinastatin 1.2 million units per day
Drug: ulinastatin
Patients will receive the study drugs for 7 to 14 days
Other Names:
  • UTI
  • urinary trypsin inhibitor
  • bikunin
Placebo Comparator: control group
Placebo
Drug: placebo
Patients will receive the placebo for 7 to 14 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence of adverse events(AEs) which can not excluded relatedness with study Product
Time Frame: Day 1 to Day 90
Day 1 to Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes of PaO2/FiO2 ratio
Time Frame: Day 0 and Day 1 to within 24h after the last treatment
Day 0 and Day 1 to within 24h after the last treatment
Days alive and off ventilator
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Days in the ICU
Time Frame: Day 1 to Day 14
Day 1 to Day 14
Changes of pulmonary compliance
Time Frame: Day 1 , Day 3 ,Day7 and within 24h after the last treatment
Day 1 , Day 3 ,Day7 and within 24h after the last treatment
Rate of new organ failure
Time Frame: Day 1 to Day 90
Day 1 to Day 90
Changes of APACHEⅡ Score from baseline
Time Frame: Day 3 ,Day7 and within 24h after the last treatment
Day 3 ,Day7 and within 24h after the last treatment
Changes of Murray Lung Injury Score from baseline
Time Frame: Day 3 ,Day7 and within 24h after the last treatment
Day 3 ,Day7 and within 24h after the last treatment
Changes of Sequential Organ Failure Assessment (SOFA) score from baseline
Time Frame: Day 3 ,Day7 and within 24h after the last treatment
Day 3 ,Day7 and within 24h after the last treatment
All-cause mortality
Time Frame: Day 28 , Day 90 and Day 1 to Day 14
Day 28 , Day 90 and Day 1 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Techpool Bio-Pharma Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Guangzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yimin Li, Doctor, First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTI-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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