U-TRYP Solution for injection Ref.[51006] Active ingredients: Ulinastatin

1. Aprospective, multicentric, double-blind, randomised, phase III clinical study was conducted to compare the efficacy and safety of intravenous Ulinastatin versus placebo along with standard supportive care in subjects of severe sepsis. Of the 122 randomized subjects, 114 completed the study (55 subjects in the Ulinastatin group and 59 subjects in the control group). The 28 day all-cause mortality was 4 subjects in the Ulinastatin group vs 12 in the placebo group (p=0.0448). This difference was statistically significant. 10 subjects in the Ulinastatin group and 20 subjects in the Placebo group had new organ dysfunction (p=0.0569). Though there was a trend towards less incidence of new organ failure in the Ulinastatin group, this was just short of statistical significance. Mean hospital stay in the Ulinastatin group was 13.59±6.83 days vs. 26.21±5.36 days in the Placebo group. This difference was statistically significant (p=0.001). Number of ventilator free days up to day 28 end-of-study were 19.44±10.61 days in the Ulinastatin group and 10.18±12.54 days in the Placebo group. This difference was found to be statistically significant (p=0.019). There were no infusion related toxicities in the study. Thus, treatment with Ulinastatin effectively reduced mortality in patients with severe sepsis when used as an adjunctive therapy in addition to standard therapy and ICU care. The reduction in mortality was accompanied by a shorter stay in the hospital and a shorter duration of ventilator and vasopressor usage with no side-effects seen in the study population.

2. Aprospective, multicenter, double-blind, randomized, phase III clinical study was conducted to compare the efficacy and safety of intravenous ulinastatin versus placebo along with standard supportive care in subjects with mild and severe acute pancreatitis. Of the 135 randomized subjects, 129 completed the study (62 subjects in the mild group and 67 subjects in the severe group). Efficacy was evaluated in the MITT population of 65 subjects in the Ulinastatin group and 64 subjects in the Placebo group. The 22-day all-cause mortality was reduced significantly from 18.8% in the placebo group to 2.8% in the Ulinastatin group in the severe pancreatitis subjects. New-onset organ failure decreased from 90% in the placebo group to 34% in the Ulinastatin group; this was statistically significant. Hospital stay was shorter in the Ulinastatin group. The reduction of Serum CRP was comparable in the two treatment groups. There was only one incidence of infusion-related toxicity (transient rash). The number of adverse events, all of a non-serious nature, were less in the study group vs control group (in mild patients 24 vs 34 and in severe patients 23 vs 45). Thus, treatment with Ulinastatin effectively reduced mortality and morbidity in patients with severe pancreatitis when used as an adjunctive therapy in addition to standard therapy. The reduction in mortality was accompanied by a shorter stay in the hospital and less complications.