Pleural EffusionPhase 2NCT04159831
A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
A Phase 2 study testing LTI-01 in people with Pleural Effusion, run by Rein Therapeutics at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- LTI-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 33 sitesUnited States
- Study dates
- 26 Sep 2020to 28 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80445
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21205
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University
Columbus, Ohio, 43210
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27705
INOVA
Fairfax, Virginia, 22031
The Pennsylvania State University
Hershey, Pennsylvania, 17033
The University of Texas Health Science Center
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
The University of Kansas Medical Center
Kansas City, Kansas, 66160
St. Luke's Health System
Kansas City, Missouri, 64111
UC San Diego Health Jacobs Medical Center
La Jolla, California, 92037
University of California (UCLA)
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Yale School of Medicine
New Haven, Connecticut, 06519
CHI CUMC Bergan Mercy
Omaha, Nebraska, 68124
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
North Shore - Long Island Jewish Medical Center
Queens, New York, 11040
Virginia Commonwealth University
Richmond, Virginia, 23219
Mayo Clinic
Rochester, Minnesota, 55905
UC Davis Medical Group
Sacramento, California, 95816
University of Utah
Salt Lake City, Utah, 84112
Washington University
St Louis, Missouri, 63110
About this study
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
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.
- Conditions
- Pleural Effusion
- Being tested
- LTI-01, Placebo
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTI-01Drug
single-chain urokinase plasminogen activator, scuPA
PlaceboDrug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| 400,000 U LTI-01 | Experimental | 400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally Receives: Drug: LTI-01 |
| 800,000 U LTI-01 | Experimental | 800,000 U LTI-01 qd x 3 days administered intrapleurally Receives: Drug: LTI-01 |
| 1,200,000 U LTI-01 | Experimental | 1,200,000 U LTI-01 qd x 3 days administered intrapleurally Receives: Drug: LTI-01 |
| Placebo | Placebo comparator | placebo (normal saline) 6ml qd x 3 days administered intrapleurally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post treatment (Day 4/Hospital discharge or at time of treatment failure)
Secondary outcomes (1)
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
Measured: Post treatment (Day 4 or at time of treatment failure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start26 Sep 2020
- Primary completion31 Mar 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rein Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159831
- Sponsor's protocol ID
- LTI-01-2001
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2019
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lamb CR, Akulian J, Musani A, Shojaee S, Chen A, Kurman J, Jani P, Senitko M, Ahmad D, Wahidi M, Ansari S, Abu-Hijleh M, Ma KC, Puchalski J, Yarmus L, Kheir F, Maldonado F, Cheng G, Alvarado C, Karan SP, Windsor B, Rahman NM, Shoemaker S, Idell S. The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions. Respir Res. 2026 Jun 17. doi: 10.1186/s12931-026-03782-4. Online ahead of print.
PubMed 42310706
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04159831
- Acronym / sponsor ID
- LTI-01-2001
- Conditions
- Pleural Effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rein TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 400,000 U LTI-01 | Experimental | Drug: LTI-01400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally |
| 800,000 U LTI-01 | Experimental | Drug: LTI-01800,000 U LTI-01 qd x 3 days administered intrapleurally |
| 1,200,000 U LTI-01 | Experimental | Drug: LTI-011,200,000 U LTI-01 qd x 3 days administered intrapleurally |
| Placebo | Placebo comparator | Drug: Placeboplacebo (normal saline) 6ml qd x 3 days administered intrapleurally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTI-01single-chain urokinase plasminogen activator, scuPA | Drug | 1,200,000 U LTI-01, 400,000 U LTI-01, 800,000 U LTI-01 |
| Placebonormal saline | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Relative change in pleural opacity
Time frame: Post treatment (Day 4 or at time of treatment failure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 42310706Lamb CR, Akulian J, Musani A, Shojaee S, Chen A, Kurman J, Jani P, Senitko M, Ahmad D, Wahidi M, Ansari S, Abu-Hijleh M, Ma KC, Puchalski J, Yarmus L, Kheir F, Maldonado F, Cheng G, Alvarado C, Karan SP, Windsor B, Rahman NM, Shoemaker S, Idell S. The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions. Respir Res. 2026 Jun 17. doi: 10.1186/s12931-026-03782-4. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LTI-01 in people with Pleural Effusion, run by Rein Therapeutics at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of referral to surgery (time frame: Post treatment (Day 4/Hospital discharge or at time of treatment failure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.