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 : August 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pleural Effusion | Drug: LTI-01 Drug: Placebo | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: 400,000 U LTI-01
400,000 U LTI-01 qd x 3 days administered intrapleurally
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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
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Drug: LTI-01
single-chain urokinase plasminogen activator, scuPA |
Placebo Comparator: Placebo
placebo (normal saline) 6ml qd x 3 days administered intrapleurally
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Drug: Placebo
normal saline |
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Contact: Laura Emery, MPSH | 303-902-6308 | lemery@lungtx.com | |
Contact: Anne Kinney, MSPH | 720-470-4743 | akinney@lungtx.com |

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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pleural Effusion Pleural Diseases Respiratory Tract Diseases |