The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
NCT02895191 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2018-04-20
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.
Conditions
- Acute Respiratory Distress Syndrome
Interventions
- DRUG
-
ulinastatin
Patients will receive the study drugs for 7 to 14 days
- DRUG
-
Patients will receive the placebo for 7 to 14 days
Sponsors & Collaborators
-
The First Affiliated Hospital of Guangzhou Medical University
collaborator OTHER -
Techpool Bio-Pharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yimin Li, Doctor · First Affiliated Hospital of Guangzhou Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2019-09-30
- Completion
- 2019-12-31
Countries
- China
Study Locations
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