DAIICHI Study

Condition: Pulmonary embolism

Eligibility

Key Inclusion Criteria

  • 18-75 years old with body weight between 50-130 kg (110-286 lbs)
  • Admitted to the hospital with a clinical diagnosis of acute PE with an onset of symptoms in the five days prior to diagnosis categorized as low-risk, intermediate-risk or submassive PE and for whom catheter-based therapy is not planned

Key Exclusion Criteria

  • Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable
  • 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

Full Study Name

A Phase IB, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Single Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokenetics and Pharmacodynamics of DS-1040B When Added to Standard-of-Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism (IRB no. 45056)

Summary

This study focuses on individuals who have a blood clot in their lung(s) called a pulmonary embolism (PE). Normal standard of care for a blood clot is treatment with heparin followed by a blood thinner. The purpose of the study is to evaluate the safety of increasing doses of an investigational drug called DS-1040b when administered with standard-of-care treatment and to assess whether adding this drug to standard of care may help in the treatment of blood clots. Researchers aim to determine the best way to give DS-1040b and which dose of the drug is safe to use. Participants will be randomly assigned to receive either DS-1040b or placebo (inactive substance).

Phase

Phase I

Principal Investigator

Victor Tapson, MD

Contact
Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org