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

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ClinicalTrials.gov Identifier: NCT04159831
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Lung Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date December 10, 2020
Actual Study Start Date  ICMJE September 26, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
Relative change in pleural opacity [ Time Frame: Post treatment (Day 4 or at time of treatment failure) ]
Change from baseline in pleural opacity as assessed by chest CT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pleural Effusion
Intervention  ICMJE
  • Drug: LTI-01
    single-chain urokinase plasminogen activator, scuPA
  • Drug: Placebo
    normal saline
Study Arms  ICMJE
  • Experimental: 400,000 U LTI-01
    400,000 U LTI-01 qd x 3 days administered intrapleurally
    Intervention: Drug: LTI-01
  • Experimental: 800,000 U LTI-01
    800,000 U LTI-01 qd x 3 days administered intrapleurally
    Intervention: Drug: LTI-01
  • Experimental: 1,200,000 U LTI-01
    1,200,000 U LTI-01 qd x 3 days administered intrapleurally
    Intervention: Drug: LTI-01
  • Placebo Comparator: Placebo
    placebo (normal saline) 6ml qd x 3 days administered intrapleurally
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
160
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2019)
100
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Emery, MPSH 303-902-6308 lemery@lungtx.com
Contact: Anne Kinney, MSPH 720-470-4743 akinney@lungtx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159831
Other Study ID Numbers  ICMJE LTI-01-2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lung Therapeutics, Inc
Study Sponsor  ICMJE Lung Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lung Therapeutics, Inc
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP