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

NCT03316729 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: DS9231-A-U2012017-000552-25
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Embolism

Keywords

Sub-massive acute pulmonary embolism

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (13)

• 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

• 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

Study Arms (2)

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

Drug: DS-9231

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DS-9231 DRUG

DS-9231 in saline solution for intravenous infusion

Also known as: Investigational product

DS-9231

Placebo DRUG

Placebo is matching saline solution for intravenous infusion

Also known as: Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ascending doses in sequential cohorts (1-3) will be evaluated against placebo

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: January 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 24, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.