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

Lung Therapeutics

Status and phase: Completed; Phase 2

Conditions: Pleural Effusion

Treatments: Drug: LTI-01; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04159831

LTI-01-2001

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

44 participants in 4 patient groups, including a placebo group

400,000 U LTI-01

Experimental group

Description:

400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally

Treatment:

Drug: LTI-01

800,000 U LTI-01

Experimental group

Description:

800,000 U LTI-01 qd x 3 days administered intrapleurally

Treatment:

Drug: LTI-01

1,200,000 U LTI-01

Experimental group

Description:

1,200,000 U LTI-01 qd x 3 days administered intrapleurally

Treatment:

Drug: LTI-01

Placebo

Placebo Comparator group

Description:

placebo (normal saline) 6ml qd x 3 days administered intrapleurally

Treatment:

Drug: Placebo