Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
400,000 U LTI-01
400,000 U LTI-01 qd x 3 days administered intrapleurally
  • Drug: LTI-01
    single-chain urokinase plasminogen activator, scuPA
Experimental
800,000 U LTI-01
800,000 U LTI-01 qd x 3 days administered intrapleurally
  • Drug: LTI-01
    single-chain urokinase plasminogen activator, scuPA
Experimental
1,200,000 U LTI-01
1,200,000 U LTI-01 qd x 3 days administered intrapleurally
  • Drug: LTI-01
    single-chain urokinase plasminogen activator, scuPA
Placebo Comparator
Placebo
placebo (normal saline) 6ml qd x 3 days administered intrapleurally
  • Drug: Placebo
    normal saline

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Abimbola Samuel Akinseye-Kolapo
205-934-9282

More Details

Status
Recruiting
Sponsor
Lung Therapeutics, Inc

Study Contact

Laura Emery, MPSH
303-902-6308
lemery@lungtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.