Clinical trial NCT03316729: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pulmonary Embolism
Keywords: Sub-massive acute pulmonary embolism
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Ascending doses in sequential cohorts (1-3) will be evaluated against placebo
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Percent change from baseline in total thrombus volume
timeFrame: Baseline, 48-96 hours after study drug administration
measure: Percentage of participants with various gradations of decrease in total thrombus volume
timeFrame: Baseline, 48-96 hours after study drug administration
measure: Number of participants with major or clinically relevant nonmajor bleeding
timeFrame: within 7 days after study drug administration
measure: Number of participants with adverse events
timeFrame: within 30 days after study drug administration
Secondary outcomes:
measure: Percent change from baseline in total thrombus volume
timeFrame: Baseline, 30 days after study drug administration
measure: Percentage of participants with with various gradations of decrease in total thrombus volume
timeFrame: 30 days after study drug administration
measure: Percent change from baseline in RV/ left ventricle (LV) diameter ratio
timeFrame: Baseline, 48-96 hours and 30 days after study drug administration
measure: Number of participants with PE-related deaths
timeFrame: within 30 days after study drug administration
measure: Number of participants who died from any cause
timeFrame: within 30 days after study drug administration
measure: Percentage of participants with clinical deterioration requiring additional rescue therapy for PE
timeFrame: within 30 days after study drug administration
measure: Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)
timeFrame: within 30 days after study drug administration
measure: Participant-reported quality of life on a proprietary scale
timeFrame: Baseline, Day 30 after study drug administration
measure: Number of participants with major or clinically relevant nonmajor bleeding
timeFrame: within 30 days after study drug administration
measure: Number of participants re-hospitalized for any reason
timeFrame: within 30 days after study drug administration
measure: Number of participants with non-bleeding adverse events (AEs)
timeFrame: within 30 days after study drug administration
measure: Number of participants with anti-drug antibodies (ADAs)
timeFrame: within 30 days after study drug administration
measure: Plasma concentration of DS-9231
timeFrame: Baseline to 30 days after study drug administration
Other outcomes:
Locations:
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: