A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| 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
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 : | September 2021 |
| Estimated Study Completion Date : | March 2022 |
| 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 |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
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
Contacts
| Contact: Laura Emery, MPSH | 303-902-6308 | lemery@lungtx.com | |
| Contact: Anne Kinney, MSPH | 720-470-4743 | akinney@lungtx.com |
Locations
Show 22 study locations
Sponsors and Collaborators
Lung Therapeutics, Inc
| 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: | December 10, 2020 |
| Last Verified: | December 2020 |
| 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 |
Additional relevant MeSH terms:
|
Pleural Effusion Pleural Diseases Respiratory Tract Diseases |