DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)
- Registration Number
- NCT03316729
- Lead Sponsor
- Daiichi Sankyo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description DS-9231 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 Placebo Placebo In conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator
- Primary Outcome Measures
Name Time Method Percent change from baseline in total thrombus volume Baseline, 48-96 hours after study drug administration Number of participants with major or clinically relevant nonmajor bleeding within 7 days after study drug administration Percentage of participants with various gradations of decrease in total thrombus volume Baseline, 48-96 hours after study drug administration Number of participants with adverse events within 30 days after study drug administration
- Secondary Outcome Measures
Name Time Method Percentage of participants with with various gradations of decrease in total thrombus volume 30 days after study drug administration Percent change from baseline in total thrombus volume Baseline, 30 days after study drug administration Percent change from baseline in RV/ left ventricle (LV) diameter ratio Baseline, 48-96 hours and 30 days after study drug administration Number of participants with PE-related deaths within 30 days after study drug administration Number of participants who died from any cause within 30 days after study drug administration Percentage of participants with clinical deterioration requiring additional rescue therapy for PE within 30 days after study drug administration Number of participants with non-bleeding adverse events (AEs) within 30 days after study drug administration Number of participants with anti-drug antibodies (ADAs) within 30 days after study drug administration Plasma concentration of DS-9231 Baseline to 30 days after study drug administration Number of participants with with recurrent, objectively documented venous thromboembolism (VTE) within 30 days after study drug administration Participant-reported quality of life on a proprietary scale Baseline, Day 30 after study drug administration Number of participants re-hospitalized for any reason within 30 days after study drug administration Number of participants with major or clinically relevant nonmajor bleeding within 30 days after study drug administration