TS23 for Pulmonary Embolism

(NAIL-IT Trial)

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Translational Sciences, Inc.

Must not be taking: Thrombolytics, Anticoagulants, Dual antiplatelets

Disqualifiers: Bleeding risk, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TS23 to see if it can safely help dissolve blood clots in the lungs of patients with significant but not immediately life-threatening clots. The drug works by breaking down these clots to improve blood flow and breathing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have been on certain anticoagulants like heparin for 48 hours before joining. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug TS23 for treating pulmonary embolism?

The research on alteplase, a drug similar to TS23, shows that it can quickly improve heart function and blood flow in the lungs for patients with pulmonary embolism, leading to fewer serious health problems compared to using heparin alone. ^{1 2 3 4 5}

Research Team

Guy L Reed, MD

Principal Investigator

Translational Sciences

Eligibility Criteria

This trial is for adults over 18 with a recent pulmonary embolism (PE) confirmed by scan, showing specific heart dysfunction but stable blood pressure. It's not for those at high bleeding risk, with certain liver conditions, low blood counts, or severe kidney issues. Pregnant or breastfeeding women and those not using effective birth control are excluded.

Inclusion Criteria

My blood pressure is stable and above 90 mm Hg.

I was diagnosed with a lung clot in a major artery less than 5 days ago.

My heart scan shows right ventricle enlargement compared to the left.

Exclusion Criteria

You have a history of testing positive for Hepatitis B or Hepatitis C.

My liver is healthy and my liver enzyme levels are not three times above the normal limit.

I have a bleeding disorder that makes me bleed easily.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending doses of TS23 or placebo with standard of care anticoagulation

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

Treatment Details

Interventions

• TS23

Trial Overview The NAIL-IT Trial is testing TS23 against a placebo in phase II to see if it can safely dissolve blood clots in the lungs. Participants will be randomly assigned to either the drug or placebo group.

Participant Groups

Group I: Low dose TS23 Experimental Treatment 1 Intervention

TS23 low dose + SOC anticoagulation

Group II: Intermediate dose TS23 Experimental Treatment 1 Intervention

TS23 medium dose + SOC anticoagulation

Group III: Higher dose TS23 Experimental Treatment 1 Intervention

TS23 highest dose + SOC anticoagulation

Group IV: Placebo Placebo Group 1 Intervention

Placebo + standard of care (SOC) anticoagulation

Who Is Running the Clinical Trial?

Translational Sciences, Inc.

Lead Sponsor

Trials

3

Recruited

360+

References

1. England pubmed.ncbi.nlm.nih.gov

Alteplase versus heparin in acute pulmonary embolism: randomised trial assessing right-ventricular function and pulmonary perfusion. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Can the tandem measurement of age adjusted D-dimer and tissue plasminagen activator improve the clinical utility of a conventional D-dimer in the pulmonary embolism diagnosis? [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Spiral computed tomographic pulmonary angiography for investigating suspected pulmonary embolism: clinical outcomes. [2019]

4. China pubmed.ncbi.nlm.nih.gov

[Assessment of treatment regimens in 58 cases with acute pulmonary embolism]. [2008]

5. Germany pubmed.ncbi.nlm.nih.gov

Treatment of pulmonary embolism with full-dose heparin, streptokinase or embolectomy--results and indications. [2007]