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

Pulmonary Embolism Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03316729
• Other study ID #: DS9231-A-U201
• Secondary ID: 2017-000552-25
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2018
• Est. completion date: February 2020

Study information

• Verified date: November 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• DS-9231
DS-9231 in saline solution for intravenous infusion
• Placebo
Placebo is matching saline solution for intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in total thrombus volume		Baseline, 48-96 hours after study drug administration
Primary	Percentage of participants with various gradations of decrease in total thrombus volume		Baseline, 48-96 hours after study drug administration
Primary	Number of participants with major or clinically relevant nonmajor bleeding		within 7 days after study drug administration
Primary	Number of participants with adverse events		within 30 days after study drug administration
Secondary	Percent change from baseline in total thrombus volume		Baseline, 30 days after study drug administration
Secondary	Percentage of participants with with various gradations of decrease in total thrombus volume		30 days after study drug administration
Secondary	Percent change from baseline in RV/ left ventricle (LV) diameter ratio		Baseline, 48-96 hours and 30 days after study drug administration
Secondary	Number of participants with PE-related deaths		within 30 days after study drug administration
Secondary	Number of participants who died from any cause		within 30 days after study drug administration
Secondary	Percentage of participants with clinical deterioration requiring additional rescue therapy for PE		within 30 days after study drug administration
Secondary	Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)		within 30 days after study drug administration
Secondary	Participant-reported quality of life on a proprietary scale		Baseline, Day 30 after study drug administration
Secondary	Number of participants with major or clinically relevant nonmajor bleeding		within 30 days after study drug administration
Secondary	Number of participants re-hospitalized for any reason		within 30 days after study drug administration
Secondary	Number of participants with non-bleeding adverse events (AEs)		within 30 days after study drug administration
Secondary	Number of participants with anti-drug antibodies (ADAs)		within 30 days after study drug administration
Secondary	Plasma concentration of DS-9231		Baseline to 30 days after study drug administration