NCT04159831

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions

A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-ranging Study Evaluating LTI-01 (Single-chain Urokinase Plasminogen Activator, scuPA) in Patients With Infected, Non-draining Pleural Effusions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Rein Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The LTI-01-2001 study is a double-blind, placebo-controlled, Phase 2 study to evaluate LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
DRUG	LTI-01	single-chain urokinase plasminogen activator, scuPA
DRUG	Placebo	normal saline

Timeline

• Start date: 2020-09-26
• Primary completion: 2022-03-31
• Completion: 2022-07-28
• First posted: 2019-11-12
• Last updated: 2023-03-30

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study