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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159831
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Lung Therapeutics, Inc

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Drug: LTI-01 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence of referral to surgery [ Time Frame: Post treatment (Day 4/Hospital discharge or at time of treatment failure) ]
    Treatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery


Secondary Outcome Measures :
  1. Relative change in pleural opacity [ Time Frame: Post treatment (Day 4 or at time of treatment failure) ]
    Change from baseline in absolute pleural opacity and relative change from baseline in pleural opacity volume assessed by chest CT at Day 4



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159831


Contacts
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Contact: Laura Emery, MPSH 303-902-6308 lemery@lungtx.com
Contact: Anne Kinney, MSPH 720-470-4743 akinney@lungtx.com

Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80445
Contact: Jordan Stumph    303-724-6052      
Principal Investigator: Ali Musani, MD         
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Contact: Jenna Los    410-955-5288      
Principal Investigator: Lonny Yarmus, DO         
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: Erick Flores    781-475-8916      
Principal Investigator: Fayez Kheir, MD         
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact: Ashley Delgado, BS    919-349-0496      
Principal Investigator: Jason Akulian, MD         
Duke University
Durham, North Carolina, United States, 27705
Contact: Kathleen Coles    919-668-3812      
Principal Investigator: Momen M Wahidi, MD, MBA         
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Contact: Jamaal Saleh, BS    614-366-2258      
Principal Investigator: Jasleen Pannu, MD         
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Michelle Andronov    215-349-8726      
Principal Investigator: Kevin C Ma, MD         
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Contact: Adetoun Sodimu, MPH, MBA    214-645-6493      
Principal Investigator: Muhanned Abu-Hijleh, MD         
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Contact: Lisa Weaver    801-587-7855      
Principal Investigator: Sikandar Ansari, MD         
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Contact: Amy Frayser    804-828-7966      
Principal Investigator: Samira Shojaee, MD         
Sponsors and Collaborators
Lung Therapeutics, Inc
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Responsible Party: Lung Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT04159831    
Other Study ID Numbers: LTI-01-2001
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases