At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 347 enrolled
Drug / intervention
ulinastatin +1 moredrug
Likely dose
ulinastatin 400,000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China
In Brief
A Phase 4 clinical trial evaluating ulinastatin and Placebo for Sepsis and Septic Shock. Completed, enrolled 347 participants across 1 site.
Detailed Summary
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis, Septic Shock
CountriesChina
CollaboratorsTechpool Bio-Pharma Co., Ltd.
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartDec 2016
Primary CompletionMay 2021
Study CompletionAug 2021
TodayJul 2026
First PostedJan 6, 2016
Enrollment StartDec 1, 2016
Primary CompletionMay 1, 2021
Study CompletionAug 1, 2021
TodayJul 3, 2026
Enrollment to primary: 4.4 yearsPosted 10.5 years ago
Interventions
ulinastatindrug
ulinastatin 400,000 IU every 8 hours for 10 days
Placebodrug
matching placebo every 8 hours for 10 days