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

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

Tracking Information

• First Submitted Date: November 4, 2019
• First Posted Date: November 12, 2019
• Last Update Posted Date: December 10, 2020
• Actual Study Start Date: September 26, 2020
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pleural Effusion

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 12, 2020): 160
• Original Estimated Enrollment (submitted: November 8, 2019): 100
• Estimated Study Completion Date: March 2022
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Laura Emery, MPSH; 303-902-6308; lemery@lungtx.com

Contact: Anne Kinney, MSPH; 720-470-4743; akinney@lungtx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04159831
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Lung Therapeutics, Inc
• Study Sponsor: Lung Therapeutics, Inc
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Lung Therapeutics, Inc
• Verification Date: December 2020