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

NCT04159831 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: LTI-01-2001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 33

Brief 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.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relative change in pleural opacity

  Post treatment (Day 4 or at time of treatment failure)

Study Arms (4)

400,000 U LTI-01

EXPERIMENTAL

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

Drug: LTI-01

800,000 U LTI-01

EXPERIMENTAL

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

Drug: LTI-01

1,200,000 U LTI-01

EXPERIMENTAL

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

Drug: LTI-01

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LTI-01 DRUG

single-chain urokinase plasminogen activator, scuPA

1,200,000 U LTI-01; 400,000 U LTI-01; 800,000 U LTI-01

Placebo DRUG

normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rein Therapeutics: lead

Study Sites (33)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UC San Diego Health Jacobs Medical Center

La Jolla, California, 92037, United States

Location

University of California (UCLA)

Los Angeles, California, 90095, United States

Location

UC Davis Medical Group

Sacramento, California, 95816, United States

Location

University of Colorado

Aurora, Colorado, 80445, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

St. Luke's Health System

Kansas City, Missouri, 64111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

CHI CUMC Bergan Mercy

Omaha, Nebraska, 68124, United States

Location

North Shore - Long Island Jewish Medical Center

Queens, New York, 11040, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

The Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

INOVA

Fairfax, Virginia, 22031, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pleural Effusion

Interventions

fibrinolytic agent LTI-01

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 12, 2019
• Study Start: September 26, 2020
• Primary Completion: March 31, 2022
• Study Completion: July 28, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)