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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ulinastatin
placebo
Sponsored by
Techpool Bio-Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • Beijing Anzhen Hospital, Capital Medical University
  • Guangzhou First People's Hospital
  • First Affiliated Hospital of Guangzhou Medical University
  • Hainan General Hospital
  • Huadong Hospital,Fudan University
  • Shanghai Sixth People's Hospital
  • West China Hospital,Sichuan Unversity
  • The First Affiliated Hospital of Xinjiang Medical University
  • Zhejiang Hospital
  • Lishui City People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

control group

Arm Description

Cohort 1- Ulinastatin 4.8 million units per day

Cohort 2- Ulinastatin 2.4 million units per day

Cohort 3- Ulinastatin 1.2 million units per day

Placebo

Outcomes

Primary Outcome Measures

The incidence of adverse events(AEs) which can not excluded relatedness with study Product

Secondary Outcome Measures

Changes of PaO2/FiO2 ratio
Days alive and off ventilator
Days in the ICU
Changes of pulmonary compliance
Rate of new organ failure
Changes of APACHEⅡ Score from baseline
Changes of Murray Lung Injury Score from baseline
Changes of Sequential Organ Failure Assessment (SOFA) score from baseline
All-cause mortality

Full Information

First Posted
July 21, 2016
Last Updated
April 19, 2018
Sponsor
Techpool Bio-Pharma Co., Ltd.
Collaborators
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02895191
Brief Title
The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Techpool Bio-Pharma Co., Ltd.
Collaborators
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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．

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Cohort 1- Ulinastatin 4.8 million units per day
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Cohort 2- Ulinastatin 2.4 million units per day
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Cohort 3- Ulinastatin 1.2 million units per day
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ulinastatin
Other Intervention Name(s)
UTI, urinary trypsin inhibitor, bikunin
Intervention Description
Patients will receive the study drugs for 7 to 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Patients will receive the placebo for 7 to 14 days
Primary Outcome Measure Information:
Title
The incidence of adverse events(AEs) which can not excluded relatedness with study Product
Time Frame
Day 1 to Day 90
Secondary Outcome Measure Information:
Title
Changes of PaO2/FiO2 ratio
Time Frame
Day 0 and Day 1 to within 24h after the last treatment
Title
Days alive and off ventilator
Time Frame
Day 1 to Day 28
Title
Days in the ICU
Time Frame
Day 1 to Day 14
Title
Changes of pulmonary compliance
Time Frame
Day 1 , Day 3 ,Day7 and within 24h after the last treatment
Title
Rate of new organ failure
Time Frame
Day 1 to Day 90
Title
Changes of APACHEⅡ Score from baseline
Time Frame
Day 3 ,Day7 and within 24h after the last treatment
Title
Changes of Murray Lung Injury Score from baseline
Time Frame
Day 3 ,Day7 and within 24h after the last treatment
Title
Changes of Sequential Organ Failure Assessment (SOFA) score from baseline
Time Frame
Day 3 ,Day7 and within 24h after the last treatment
Title
All-cause mortality
Time Frame
Day 28 , Day 90 and Day 1 to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have provided signed written informed consent form (ICF) from the patient or the patient's legal representative; Male or Female patients ≥18 years of age; ARDS defined with using 2012 Berlin Criteria; 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: Patient with known hypersensitivity to Ulinastatin/adjuvant or patient with allergic constitution; Patients with artificial organs replacement therapy for liver or kidney； Glasgow Coma Scale (GCS)≤8； Cardiogenic pulmonary edema , and the cardiogenic pulmonary edema is as the only or primary reason for respiratory failure; ARDS caused by burning, drowning, poisoning; 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; Neutrophils<1.5×10^9/L Moribund patients (i.e.,expected to live no longer than 24 hours) or with recent (within 7days or anytime during present hospitalization) cardiopulmonary arrest; Patients need long-term glucocorticoid treatment or need to be treated with immunosuppressive drugs; No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol; Lung transplant patients; Patients with malignancy, expected to live no longer than 6 months; Pregnant or breast-feeding; Patients who have participated in any clinical study within 3 months prior to the screening; Any condition that in the opinion of the investigator would add the patient's risk or jeopardize the operation of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yimin Li, Doctor
Organizational Affiliation
First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Huadong Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghia
ZIP/Postal Code
200233
Country
China
Facility Name
West China Hospital,Sichuan Unversity
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310030
Country
China
Facility Name
Lishui City People's Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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