The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions - PubMed
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- #Clinical Trial
- #Enzymatic Therapy
- #Pleural Infection
- The LTI-01-2001 phase 2a trial tested intrapleural LTI-01 (single chain urokinase) in patients with infected, non-draining pleural effusions.
- It was a randomized, double-blind, placebo-controlled, multi-center study comparing doses of 400,000, 800,000, or 1,200,000 Units versus placebo, administered once daily for up to 3 days.
- The primary endpoint was treatment failure within 7 days, with no significant difference between LTI-01 and placebo groups overall (OR 1.04, P=0.96).
- Sensitivity analyses suggested trends of improved efficacy at the 400,000 U dose (P=0.052 and 0.147).
- Pleural opacification improved significantly in the 800,000 U group (absolute change -0.28 L, P=0.035) and in combined LTI-01 groups (P<0.03).
- No safety concerns or bleeding episodes were reported in LTI-01-treated patients.
- Conclusions indicated no statistically significant difference in treatment failure, possibly due to low recruitment, but trends toward efficacy were noted. A larger phase 2b trial is needed.