Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pulmonary Embolism, Thrombotic Disease

In brief

This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.

Key facts

Study ID

NCT02923115

Run by

Daiichi Sankyo

People needed

134

Starts

2016-06-23

Expected to finish

2019-08-05

Last updated by the study team

2023-04-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute pulmonary embolism (PE) categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
• Subjects must have a computed tomography angiography (CTA) scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
• Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
• Subjects must be able to provide written informed consent.

You may not qualify if…

• Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation;
• Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
• Subjects with PE lesions only in the sub-segmental or smaller arteries;
• Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with low molecular weight (LMW) Heparin in therapeutic doses prior to randomization;
• Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding;
• Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;
• Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding;
• Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
• Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.

Where it is running

• Pulmonary Associates of Mobile — Mobile, Alabama, United States
• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• University of California, San Diego (UCSD) Medical Center — San Diego, California, United States
• Intercoastal Medical Group — Sarasota, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Mercury Street Medical — Butte, Montana, United States
• NYU Radiology Associate — New York, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• Duke University Medical Center (DUMC) — Durham, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Capital Area Research — Camp Hill, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Medical University Graz — Graz, Austria
• Medical University Innsbruck — Innsbruck, Austria
• Medical University of Vienna — Vienna, Austria
• Universite Libre de Bruxelles (ULB) - Hopital Erasme — Brussels, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• University Hospital Leuven — Leuven, Belgium
• CHU de Brest - Hopital de la Cavale Blanche — Brest, France
• CHU Gabriel Montpied Clermont-Ferrand — Clermont-Ferrand, France
• CHU de Grenoble — La Tronche, France
• Hopital Europeen Georges Pompidou — Paris, France

Full record on ClinicalTrials.gov

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