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

Acute Respiratory Distress Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02895191
• Other study ID #: UTI-2001
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: July 21, 2016
• Last updated: April 19, 2018
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Techpool Bio-Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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．

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• ulinastatin
Patients will receive the study drugs for 7 to 14 days
• placebo
Patients will receive the placebo for 7 to 14 days

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	West China Hospital,Sichuan Unversity	Chengdu	Sichuan
China	First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Lishui City People's Hospital	Lishui	Zhejiang
China	Huadong Hospital,Fudan University	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghia
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang

Sponsors (2)

Lead Sponsor	Collaborator
Techpool Bio-Pharma Co., Ltd.	The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events(AEs) which can not excluded relatedness with study Product		Day 1 to Day 90
Secondary	Changes of PaO2/FiO2 ratio		Day 0 and Day 1 to within 24h after the last treatment
Secondary	Days alive and off ventilator		Day 1 to Day 28
Secondary	Days in the ICU		Day 1 to Day 14
Secondary	Changes of pulmonary compliance		Day 1 , Day 3 ,Day7 and within 24h after the last treatment
Secondary	Rate of new organ failure		Day 1 to Day 90
Secondary	Changes of APACHE? Score from baseline		Day 3 ,Day7 and within 24h after the last treatment
Secondary	Changes of Murray Lung Injury Score from baseline		Day 3 ,Day7 and within 24h after the last treatment
Secondary	Changes of Sequential Organ Failure Assessment (SOFA) score from baseline		Day 3 ,Day7 and within 24h after the last treatment
Secondary	All-cause mortality		Day 28 , Day 90 and Day 1 to Day 14