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

Primary Purpose

Pulmonary Embolism

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
DS-9231
Placebo
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Sub-massive acute pulmonary embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    DS-9231

    Placebo

    Arm Description

    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

    In conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator

    Outcomes

    Primary Outcome Measures

    Percent change from baseline in total thrombus volume
    Percentage of participants with various gradations of decrease in total thrombus volume
    Number of participants with major or clinically relevant nonmajor bleeding
    Number of participants with adverse events

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 17, 2017
    Last Updated
    December 20, 2018
    Sponsor
    Daiichi Sankyo, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03316729
    Brief Title
    DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)
    Official Title
    Evaluation of Safety and Thrombolytic Effect of Ascending Doses of DS-9231 (TS23) in Subjects With Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Product development cancelled.
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    February 2020 (Anticipated)
    Study Completion Date
    February 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daiichi Sankyo, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Embolism
    Keywords
    Sub-massive acute pulmonary embolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Sequential Assignment
    Model Description
    Ascending doses in sequential cohorts (1-3) will be evaluated against placebo
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DS-9231
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    In conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator
    Intervention Type
    Drug
    Intervention Name(s)
    DS-9231
    Other Intervention Name(s)
    Investigational product
    Intervention Description
    DS-9231 in saline solution for intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Matching placebo
    Intervention Description
    Placebo is matching saline solution for intravenous infusion
    Primary Outcome Measure Information:
    Title
    Percent change from baseline in total thrombus volume
    Time Frame
    Baseline, 48-96 hours after study drug administration
    Title
    Percentage of participants with various gradations of decrease in total thrombus volume
    Time Frame
    Baseline, 48-96 hours after study drug administration
    Title
    Number of participants with major or clinically relevant nonmajor bleeding
    Time Frame
    within 7 days after study drug administration
    Title
    Number of participants with adverse events
    Time Frame
    within 30 days after study drug administration
    Secondary Outcome Measure Information:
    Title
    Percent change from baseline in total thrombus volume
    Time Frame
    Baseline, 30 days after study drug administration
    Title
    Percentage of participants with with various gradations of decrease in total thrombus volume
    Time Frame
    30 days after study drug administration
    Title
    Percent change from baseline in RV/ left ventricle (LV) diameter ratio
    Time Frame
    Baseline, 48-96 hours and 30 days after study drug administration
    Title
    Number of participants with PE-related deaths
    Time Frame
    within 30 days after study drug administration
    Title
    Number of participants who died from any cause
    Time Frame
    within 30 days after study drug administration
    Title
    Percentage of participants with clinical deterioration requiring additional rescue therapy for PE
    Time Frame
    within 30 days after study drug administration
    Title
    Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)
    Time Frame
    within 30 days after study drug administration
    Title
    Participant-reported quality of life on a proprietary scale
    Time Frame
    Baseline, Day 30 after study drug administration
    Title
    Number of participants with major or clinically relevant nonmajor bleeding
    Time Frame
    within 30 days after study drug administration
    Title
    Number of participants re-hospitalized for any reason
    Time Frame
    within 30 days after study drug administration
    Title
    Number of participants with non-bleeding adverse events (AEs)
    Time Frame
    within 30 days after study drug administration
    Title
    Number of participants with anti-drug antibodies (ADAs)
    Time Frame
    within 30 days after study drug administration
    Title
    Plasma concentration of DS-9231
    Time Frame
    Baseline to 30 days after study drug administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: the safety or well-being of the participant or the participant's offspring the safety of study staff the analysis of results
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Clinical Leader
    Organizational Affiliation
    Daiichi Sankyo, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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 URL
    https://vivli.org/ourmember/daiichi-sankyo/

    Learn more about this trial

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

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