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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lung Therapeutics, Inc
• Treatments: Plasminogen

Criteria

Key Inclusion Criteria:

• Male or female ≥ 18 years of age who provide written informed consent

• Clinical presentation compatible with complicated parapneumonic pleural effusion (CPE), empyema or other type of pleural infection

• Has pleural fluid requiring drainage as determined by chest ultrasonography or by chest CT, and which is either:

• a) purulent; b) gram stain positive; c) culture positive; d) pH < 7.2; or e) glucose < 60 mg/dL (3.3 mmol/L)

• Failure to adequately drain pleural fluid ≥ 3 hours post insertion of patent chest tube within the pleural space, as evidenced by one or more of the following criteria:

• > 2 cm depth of fluid by ultrasound or CT

• < 80% drainage from chest radiograph obtained prior to chest tube insertion.

Key Exclusion Criteria:

• Current pleural infection already treated with intrapleural fibrinolytic therapy

• Evidence of ipsilateral fibrothorax (e.g. CT scan with > 0.5 cm visceral pleural thickening)

• History of multiple thoracenteses or thoracic surgical procedures within 3 months of screening

• Previous pneumonectomy on the side of the pleural effusion

• Current bilateral pleural infections

• Known non-expandable lung prior to this pleural infection

• Known or high clinical suspicion of a malignant pleural effusion

• Existing indwelling or tunneled pleural catheter

• Current infected hepatic hydrothorax or evidence of another abdominal process (e.g. pancreatic cyst or renal cyst) communicating with the pleural space

• Active bleeding, or any condition in which bleeding is either a significant risk or would be difficult to manage

• Fully anticoagulated patients on heparin, warfarin or novel oral anti-coagulants who are not able to temporarily discontinue anti-coagulants while receiving study medication and for 2 days after last dose of study medication Note: patients receiving low-molecular weight heparin for immobilization or anti-platelet agents are not excluded.

• Presence of severe metabolic derangements that would interfere with study assessments

• Systolic blood pressure >185 mmHg or diastolic blood pressure > 110 mmHg at screening

• Hemodynamically unstable and/or requires use of intravenous vasopressor therapy

• Expected survival < 3 months from a pathology other than the qualifying infected, non-draining pleural effusion (e.g. metastatic lung carcinoma)