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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000552-25 | EudraCT Number |
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Product development cancelled.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-9231 | Experimental | 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 Comparator | In conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-9231 | Drug | DS-9231 in saline solution for intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in total thrombus volume | Baseline, 48-96 hours 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 major or clinically relevant nonmajor bleeding | within 7 days after study drug administration | |
| Number of participants with adverse events | within 30 days after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in total thrombus volume | Baseline, 30 days after study drug administration | |
| Percentage of participants with with various gradations of decrease in total thrombus volume | 30 days after study drug administration |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
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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/
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.
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.
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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Ascending doses in sequential cohorts (1-3) will be evaluated against placebo
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| Placebo | Drug | Placebo is matching saline solution for intravenous infusion |
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| 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 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 with major or clinically relevant nonmajor bleeding | within 30 days after study drug administration |
| Number of participants re-hospitalized for any reason | 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |