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

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159831
• Other study ID #: LTI-01-2001
• Status: Completed
• Phase: Phase 2
• Start date: September 26, 2020
• Est. completion date: July 28, 2022

Study information

• Verified date: March 2023
• Source: Lung Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 28, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Drug:
• LTI-01
single-chain urokinase plasminogen activator, scuPA
• Placebo
normal saline

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	INOVA	Fairfax	Virginia
United States	The Pennsylvania State University	Hershey	Pennsylvania
United States	The University of Texas Health Science Center	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	St. Luke's Health System	Kansas City	Missouri
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	UC San Diego Health Jacobs Medical Center	La Jolla	California
United States	University of California (UCLA)	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	CHI CUMC Bergan Mercy	Omaha	Nebraska
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	North Shore - Long Island Jewish Medical Center	Queens	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	UC Davis Medical Group	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Lung Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of referral to surgery	Treatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery	Post treatment (Day 4/Hospital discharge or at time of treatment failure)
Secondary	Relative change in pleural opacity	Change from baseline in absolute pleural opacity and relative change from baseline in pleural opacity volume assessed by chest CT at Day 4	Post treatment (Day 4 or at time of treatment failure)