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

Sponsor

Lung Therapeutics, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04159831

Collaborator

(none)

160

Enrollment

Locations

Arms

23.2

Anticipated Duration (Months)

4.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion	Drug: LTI-01 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 26, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Primary Outcome Measures

Incidence of referral to surgery [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

Relative change in pleural opacity [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:
1. 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

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	UC San Diego Health Jacobs Medical Center	La Jolla	California	United States	92037
3	University of California (UCLA)	Los Angeles	California	United States	90095
4	UC Davis Medical Group	Sacramento	California	United States	95816
5	University of Colorado	Aurora	Colorado	United States	80445
6	Yale School of Medicine	New Haven	Connecticut	United States	06519
7	Rush University Medical Center	Chicago	Illinois	United States	60612
8	The University of Kansas Medical Center	Kansas City	Kansas	United States	66160
9	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
10	Johns Hopkins University	Baltimore	Maryland	United States	21205
11	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
12	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
13	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805
14	University of Michigan	Ann Arbor	Michigan	United States	48109
15	Mayo Clinic	Rochester	Minnesota	United States	55905
16	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
17	St. Luke's Health System	Kansas City	Missouri	United States	64111
18	Washington University	Saint Louis	Missouri	United States	63110
19	CHI CUMC Bergan Mercy	Omaha	Nebraska	United States	68124
20	North Shore - Long Island Jewish Medical Center	Queens	New York	United States	11040
21	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
22	Duke University	Durham	North Carolina	United States	27705
23	The Ohio State University	Columbus	Ohio	United States	43210
24	The Pennsylvania State University	Hershey	Pennsylvania	United States	17033
25	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
26	Temple University	Philadelphia	Pennsylvania	United States	19140
27	Vanderbilt Medical Center	Nashville	Tennessee	United States	37232
28	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
29	The University of Texas Health Science Center	Houston	Texas	United States	77030
30	University of Utah	Salt Lake City	Utah	United States	84112
31	INOVA	Fairfax	Virginia	United States	22031
32	Virginia Commonwealth University	Richmond	Virginia	United States	23219
33	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

Lung Therapeutics, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lung Therapeutics, Inc

ClinicalTrials.gov Identifier:

NCT04159831

Other Study ID Numbers:

LTI-01-2001

First Posted:

Nov 12, 2019

Last Update Posted:

Aug 24, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pleural Effusion

Study Results

No Results Posted as of Aug 24, 2021