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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 : Recruiting
First Posted : November 12, 2019
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Lung Therapeutics, Inc

Study Description
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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

Study Design
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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
Actual Study Start Date : September 26, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022
Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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)
Contacts and Locations
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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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Sponsors and Collaborators
Lung Therapeutics, Inc
More Information
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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: August 24, 2021
Last Verified: August 2021
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