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New antibody aims to dissolve lung clots with less bleeding risk

NCT ID NCT05408546

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new drug called TS23, a monoclonal antibody designed to help break down blood clots in the lungs. It is for people with intermediate-risk pulmonary embolism, a serious condition where clots block blood flow. The trial compares different doses of TS23 against a placebo to see if it safely dissolves clots and improves heart function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TS23 (a monoclonal antibody that targets a protein involved in blood clot breakdown)
What this could lead to
If successful, TS23 could offer a new, safer way to dissolve dangerous blood clots in the lungs, potentially reducing complications and improving recovery.
What could go wrong
This is an early phase 2 trial with only 64 participants, so results may not apply to everyone. The main risk is bleeding, and the drug may not work better than standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Banner University Medical Center

    Phoenix, Arizona, 85004, United States

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85004, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cottage Hospital

    Santa Barbara, California, 93105, United States

  • Fairview Hospital

    Cleveland, Ohio, 44111, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48207, United States

  • Lifebridge Health

    Baltimore, Maryland, 21215, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • Texas Tech University Health Sciences Center at El Paso

    El Paso, Texas, 79430, United States

  • Tuft University Hospital

    Boston, Massachusetts, 02116, United States

  • Wake Forest University/Atrium Health's Carolinas Medical Center

    Winston-Salem, North Carolina, 27103, United States

  • Wellstar MCG Health Medical Center

    Augusta, Georgia, 30912, United States

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