Ignite Creation Date:
2024-05-06 @ 9:05 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02895191
Status:
UNKNOWN
Last Update Posted:
2018-04-20
First Post:
2016-07-21
Brief Title:
The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress SyndromeARDS
Sponsor:
Techpool Bio-Pharma Co Ltd
Organization:
Techpool Bio-Pharma Co Ltd
Study Overview
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 SyndromeARDS
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Compared with placebo evaluate the effects and safety of UlinastatinUTI 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 1111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None