NCT02895191

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

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Techpool Bio-Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	ulinastatin	Patients will receive the study drugs for 7 to 14 days
DRUG	placebo	Patients will receive the placebo for 7 to 14 days

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2016-09-09
• Last updated: 2018-04-20

Locations

11 sites across 1 country: China