Overview

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)