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

NCT ID: NCT02895191

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-12-31

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．

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

Cohort 1- Ulinastatin 4.8 million units per day

Group Type: EXPERIMENTAL

ulinastatin

Intervention Type: DRUG

Patients will receive the study drugs for 7 to 14 days

Cohort 2

Cohort 2- Ulinastatin 2.4 million units per day

Group Type: EXPERIMENTAL

ulinastatin

Intervention Type: DRUG

Patients will receive the study drugs for 7 to 14 days

Cohort 3

Cohort 3- Ulinastatin 1.2 million units per day

Group Type: EXPERIMENTAL

ulinastatin

Intervention Type: DRUG

Patients will receive the study drugs for 7 to 14 days

control group

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Patients will receive the placebo for 7 to 14 days

Interventions

ulinastatin

Patients will receive the study drugs for 7 to 14 days

Intervention Type: DRUG

placebo

Patients will receive the placebo for 7 to 14 days

Intervention Type: DRUG

Other Intervention Names

UTI; urinary trypsin inhibitor; bikunin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Techpool Bio-Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yimin Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Guangzhou Medical University

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Hainan General Hospital

Haikou, Hainan, China

Huadong Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghia, China

West China Hospital,Sichuan Unversity

Chengdu, Sichuan, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

Lishui City People's Hospital

Lishui, Zhejiang, China

Countries

China

Other Identifiers

UTI-2001

Identifier Type: -

Identifier Source: org_study_id