Overview

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

Status:
Unknown status

Trial end date:
2019-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Techpool Bio-Pharma Co., Ltd.

Collaborator:

The First Affiliated Hospital of Guangzhou Medical University

Treatments:

Trypsin Inhibitors
Urinastatin

Criteria

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.