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

Primary Purpose

Pleural Effusion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LTI-01
Placebo
Sponsored by
Lung Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Alabama at Birmingham
  • UC San Diego Health Jacobs Medical Center
  • University of California (UCLA)
  • UC Davis Medical Group
  • University of Colorado
  • Yale School of Medicine
  • Rush University Medical Center
  • The University of Kansas Medical Center
  • University of Maryland School of Medicine
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Lahey Hospital and Medical Center
  • University of Michigan
  • Mayo Clinic
  • University of Mississippi Medical Center
  • St. Luke's Health System
  • Washington University
  • CHI CUMC Bergan Mercy
  • North Shore - Long Island Jewish Medical Center
  • University of North Carolina at Chapel Hill
  • Duke University
  • The Ohio State University
  • The Pennsylvania State University
  • University of Pennsylvania
  • Temple University
  • Vanderbilt Medical Center
  • The University of Texas Southwestern Medical Center
  • The University of Texas Health Science Center
  • University of Utah
  • INOVA
  • Virginia Commonwealth University
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

400,000 U LTI-01

800,000 U LTI-01

1,200,000 U LTI-01

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Relative change in pleural opacity
Change from baseline in absolute pleural opacity and relative change from baseline in pleural opacity volume assessed by chest CT at Day 4

Full Information

First Posted
November 4, 2019
Last Updated
March 24, 2023
Sponsor
Lung Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04159831
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lung Therapeutics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400,000 U LTI-01
Arm Type
Experimental
Arm Description
400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally
Arm Title
800,000 U LTI-01
Arm Type
Experimental
Arm Description
800,000 U LTI-01 qd x 3 days administered intrapleurally
Arm Title
1,200,000 U LTI-01
Arm Type
Experimental
Arm Description
1,200,000 U LTI-01 qd x 3 days administered intrapleurally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo (normal saline) 6ml qd x 3 days administered intrapleurally
Intervention Type
Drug
Intervention Name(s)
LTI-01
Intervention Description
single-chain urokinase plasminogen activator, scuPA
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
normal saline
Primary Outcome Measure Information:
Title
Incidence of referral to surgery
Description
Treatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery
Time Frame
Post treatment (Day 4/Hospital discharge or at time of treatment failure)
Secondary Outcome Measure Information:
Title
Relative change in pleural opacity
Description
Change from baseline in absolute pleural opacity and relative change from baseline in pleural opacity volume assessed by chest CT at Day 4
Time Frame
Post treatment (Day 4 or at time of treatment failure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UC San Diego Health Jacobs Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Davis Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80445
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CHI CUMC Bergan Mercy
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
North Shore - Long Island Jewish Medical Center
City
Queens
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Pennsylvania State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
INOVA
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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