Summary

for people ages 18-75 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic Research Organization ARO and Clinical Research Organization CRO blinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in subjects with acute submassive pulmonary embolism.

Official Title

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b When Added to Standard of Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism

Keywords

Pulmonary Embolism Thrombotic Disease Venous thromboembolism VTE PE Acute Submassive Pulmonary Embolism Embolism DS-1040b

Eligibility

You can join if…

Open to people ages 18-75

  • Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute PE categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
  • Subjects must have a 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 CAN'T join 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 LMW(low molecular weight 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.

Locations

  • University of California, San Diego (UCSD) Medical Center not yet accepting patients
    San Diego California 92103 United States
  • Cedars-Sinai Medical Center accepting new patients
    Beverly Hills California 90211 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT02923115
Phase
Phase 1/2
Study Type
Interventional
Last Updated
May 15, 2018