New treatment for blood clots in the lungs

Evaluation of the Safety and Thrombolytic Effects of Ascending Doses of TS23 in Subjects With Intermediate-Risk (Sub-Massive) Acute Pulmonary Embolism

This study is testing a new treatment called TS23 to see if it can help dissolve blood clots in the lungs for people who are stable but have signs of heart strain from a pulmonary embolism.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Translational Sciences, Inc. (Industry-sponsored)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT05408546 on ClinicalTrials.gov

What this trial studies

This Phase II trial evaluates the safety and effectiveness of TS23, a novel treatment, for patients with intermediate-risk acute pulmonary embolism. Participants will receive either TS23 or a placebo, and the study will assess the thrombolytic effect of ascending doses of TS23. The trial focuses on individuals who are hemodynamically stable but show signs of right ventricular dysfunction due to the pulmonary embolism. The goal is to determine if TS23 can effectively dissolve blood clots in the lungs.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of pulmonary embolism and evidence of right ventricular dysfunction.

Not a fit: Patients who are scheduled for thrombolytic therapy or have received anticoagulants shortly before the trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients suffering from pulmonary embolism, potentially improving outcomes and reducing complications.

How similar studies have performed: Other studies have explored thrombolytic therapies, but the specific approach of using TS23 is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects, age \>18 years;
2. PE involving a segmental or more proximal pulmonary artery confirmed by CTPA scan and with an onset of symptoms not more than 5 days prior to diagnosis;
3. Subject is hemodynamically stable with a systolic blood pressure (SBP) \>90 mm Hg;
4. Subject has evidence of RV dysfunction as indicated by a right ventricular-to-left ventricular (RV/LV) diameter ratio \> 0.9 on CTPA scan (measuring the minor axis of the right and left ventricle in the transverse plane), prior to the initiation of study drug administration.

Exclusion Criteria:

1. Subjects for whom thrombolytic therapy or thrombectomy is planned; or subjects with history of administration of thrombolytic agents within the previous 4 days;
2. Subjects receiving ≥ 48 hours of therapeutic doses of heparin or low molecular weight heparin (LMWH) or other anticoagulant therapy immediately prior to randomization;
3. Subjects with contraindications to SOC therapies such as unfractionated heparin or LMWH or oral anticoagulant, or any of the excipients (including study drug excipients);
4. Subjects who are considered at very high risk of bleeding:

   1. Known coagulation disorder with history of pathologic bleeding tendencies
   2. Subjects with prior intracranial hemorrhage, known arteriovenous malformation or aneurysm of the brain, or evidence of active bleeding;
   3. Subjects with a history of major surgery, clinically significant head trauma (in the opinion of the Principal Investigator), or stroke in the past 3 months prior to randomization;
   4. Subjects with uncontrolled hypertension defined as SBP ≥180 mm Hg and/or diastolic BP (DBP)

      ≥110 mm Hg at randomization
   5. Subjects requiring concomitant dual antiplatelet therapy
5. Subjects with Creatinine Clearance (CrCL) \< 30 mL/min or serum creatinine ≥ 2.5 mg/dL;
6. Subjects with hemoglobin \< 8.0 g/dL;
7. Subjects with a platelet count \< 100,000/µL;
8. Subjects with acute or persistent hepatitis or diagnosed active liver disease or with elevation of liver enzymes: Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 x upper limit of normal (ULN);
9. Subjects with known history of testing positive for Hepatitis B antigen or Hepatitis C antibody;
10. Subjects with known history of testing positive for the human immunodeficiency virus (HIV);
11. Subjects with life-expectancy \< 6 months;
12. Female subjects of child bearing potential with a positive pregnancy test or who are lactating, or unwilling to use highly effective methods of contraception. Highly effective methods of birth control include combination hormonal therapy (estrogen and progresterone), contraceptives administered orally, intravaginally or transdermally, progesterone-only contraceptives administered orally, by injection or implantation, use of an intrauterine device (IUD), intrauterine hormone- releasing system (IUS), bilateral tubal occlusion, partner vasectomy or sexual abstinence;
13. Subjects currently participating in another investigational study or who have participated in an investigational drug study within 30 days (or longer depending on the half-life of the investigational drug; should allow at least five half-life of the investigational drug) prior to randomization.

Where this trial is running

Los Angeles, California

• Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Guy L Reed, MD — Translational Sciences
• Study coordinator: Principal Investigator

Conditions Pulmonary Embolism