DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)

December 20, 2018 updated by: Daiichi Sankyo, Inc.

Evaluation of Safety and Thrombolytic Effect of Ascending Doses of DS-9231 (TS23) in Subjects With Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)

The primary objective of this study is to evaluate safety and initial effectiveness of DS-9231 when taken together with current standard of care. Evaluation will be done with low, medium and then high doses of DS-9231 versus placebo, in participants with medium-risk acute pulmonary embolism.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Had protocol-defined pulmonary embolism (PE)
  • Has stable systolic blood pressure (SBP) >90 mm Hg
  • Has evidence of right ventricular (RV) dysfunction
  • Has executed informed consent

Exclusion Criteria:

  • Has history or plans for thrombotic therapy outside protocol allowance
  • Has other contraindications for participation
  • Has laboratory results outside protocol-specified limits
  • Is pregnant, nursing, and/or not willing or able to use protocol-defined contraceptives
  • Has history or condition, or participated in another investigational study that (per protocol or in the opinion of the investigator) might compromise:

    1. the safety or well-being of the participant or the participant's offspring
    2. the safety of study staff
    3. the analysis of results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DS-9231
In conjunction with standard of care, participants will receive an intravenous infusion delivering DS-9231 at ascending dose levels in Cohort 1, 2, and 3
DS-9231 in saline solution for intravenous infusion
Other Names:
  • Investigational product
PLACEBO_COMPARATOR: Placebo
In conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator
Placebo is matching saline solution for intravenous infusion
Other Names:
  • Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in total thrombus volume
Time Frame: Baseline, 48-96 hours after study drug administration
Baseline, 48-96 hours after study drug administration
Percentage of participants with various gradations of decrease in total thrombus volume
Time Frame: Baseline, 48-96 hours after study drug administration
Baseline, 48-96 hours after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Time Frame: within 7 days after study drug administration
within 7 days after study drug administration
Number of participants with adverse events
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in total thrombus volume
Time Frame: Baseline, 30 days after study drug administration
Baseline, 30 days after study drug administration
Percentage of participants with with various gradations of decrease in total thrombus volume
Time Frame: 30 days after study drug administration
30 days after study drug administration
Percent change from baseline in RV/ left ventricle (LV) diameter ratio
Time Frame: Baseline, 48-96 hours and 30 days after study drug administration
Baseline, 48-96 hours and 30 days after study drug administration
Number of participants with PE-related deaths
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Number of participants who died from any cause
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Percentage of participants with clinical deterioration requiring additional rescue therapy for PE
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Participant-reported quality of life on a proprietary scale
Time Frame: Baseline, Day 30 after study drug administration
Baseline, Day 30 after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Number of participants re-hospitalized for any reason
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Number of participants with non-bleeding adverse events (AEs)
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Number of participants with anti-drug antibodies (ADAs)
Time Frame: within 30 days after study drug administration
within 30 days after study drug administration
Plasma concentration of DS-9231
Time Frame: Baseline to 30 days after study drug administration
Baseline to 30 days after study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (ACTUAL)

October 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DS9231-A-U201
  • 2017-000552-25 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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