NCT05534802 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Atal SS, Atal S
Ulinastatin - a newer potential therapeutic option for multiple organ dysfunction syndrome. J Basic Clin Physiol Pharmacol. 2016 Mar;27(2):91-9. doi: 10.1515/jbcpp-2015-0003.
Liu Y, Wang YL, Zou SH, Sun PF, Zhao Q
Effect of high-dose ulinastatin on the cardiopulmonary bypass-induced inflammatory response in patients undergoing open-heart surgery. Chin Med J (Engl). 2020 Jun 20;133(12):1476-1478. doi: 10.1097/CM9.0000000000000
Xu HY, Rong XS, Wang DP, Jiang SY, Zang ZD, Xia W, Zhang F, Yan J
Effect of urinary trypsin inhibitor on inflammatory cytokines and organ function in patients with cardiopulmonary bypass. Eur Rev Med Pharmacol Sci. 2017 May;21(9):2220-2225.

Ulinastatin Improves and Prevents Cardiac Dysfunction Induced by Cardiopulmonary Bypass by Reducing Cardiac Endothelial Permeability

Clinical trial NCT05534802 - References