Pulmonary EmbolismPhase 2NCT03316729
DS-9231 in Intermediate-risk (Sub-massive) Acute Pulmonary Embolism (PE)
A Phase 2 study testing DS-9231 in people with Pulmonary Embolism, run by Daiichi Sankyo.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- DS-9231
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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)
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
- Being tested
- DS-9231, Placebo
- Keywords
- Sub-massive acute pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-9231Drug
Also called Investigational product
DS-9231 in saline solution for intravenous infusion
PlaceboDrug
Also called Matching placebo
Placebo is matching saline solution for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in total thrombus volume
Measured: Baseline, 48-96 hours after study drug administration
Percentage of participants with various gradations of decrease in total thrombus volume
Measured: Baseline, 48-96 hours after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Measured: within 7 days after study drug administration
Number of participants with adverse events
Measured: within 30 days after study drug administration
Secondary outcomes (13)
Percent change from baseline in total thrombus volume
Measured: Baseline, 30 days after study drug administration
Percentage of participants with with various gradations of decrease in total thrombus volume
Measured: 30 days after study drug administration
Percent change from baseline in RV/ left ventricle (LV) diameter ratio
Measured: Baseline, 48-96 hours and 30 days after study drug administration
Number of participants with PE-related deaths
Measured: within 30 days after study drug administration
Number of participants who died from any cause
Measured: within 30 days after study drug administration
Percentage of participants with clinical deterioration requiring additional rescue therapy for PE
Measured: within 30 days after study drug administration
Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)
Measured: within 30 days after study drug administration
Participant-reported quality of life on a proprietary scale
Measured: Baseline, Day 30 after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Measured: within 30 days after study drug administration
Number of participants re-hospitalized for any reason
Measured: within 30 days after study drug administration
Number of participants with non-bleeding adverse events (AEs)
Measured: within 30 days after study drug administration
Number of participants with anti-drug antibodies (ADAs)
Measured: within 30 days after study drug administration
Plasma concentration of DS-9231
Measured: Baseline to 30 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study startJan 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Why it stopped: Product development cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Ascending doses in sequential cohorts (1-3) will be evaluated against placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316729
- Sponsor's protocol ID
- DS9231-A-U201
- Other IDs
- 2017-000552-25, 2017
- Status last verified
- Nov 2017
- First submitted
- 17 Oct 2017
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03316729
- Acronym / sponsor ID
- DS9231-A-U201
- Conditions
- Pulmonary Embolism
- Keywords
- Sub-massive acute pulmonary embolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Product development cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jan 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Ascending doses in sequential cohorts (1-3) will be evaluated against placebo
| Arm | Type | Receives |
|---|---|---|
| DS-9231 | Experimental | Drug: DS-9231In 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 | Drug: PlaceboIn conjunction with standard of care, participants will receive an intravenous infusion delivering only saline solution as matching placebo comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-9231Also: Investigational productDS-9231 in saline solution for intravenous infusion | Drug | DS-9231 |
| PlaceboAlso: Matching placeboPlacebo is matching saline solution for intravenous infusion | Drug | Placebo |
Primary outcome
Percent change from baseline in total thrombus volume
Time frame: Baseline, 48-96 hours after study drug administration
Percentage of participants with various gradations of decrease in total thrombus volume
Time frame: Baseline, 48-96 hours after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Time frame: within 7 days after study drug administration
Number of participants with adverse events
Time frame: within 30 days after study drug administration
13 secondary outcomes
Percent change from baseline in total thrombus volume
Time frame: Baseline, 30 days after study drug administration
Percentage of participants with with various gradations of decrease in total thrombus volume
Time frame: 30 days after study drug administration
Percent change from baseline in RV/ left ventricle (LV) diameter ratio
Time frame: Baseline, 48-96 hours and 30 days after study drug administration
Number of participants with PE-related deaths
Time frame: within 30 days after study drug administration
Number of participants who died from any cause
Time frame: within 30 days after study drug administration
Percentage of participants with clinical deterioration requiring additional rescue therapy for PE
Time frame: within 30 days after study drug administration
Number of participants with with recurrent, objectively documented venous thromboembolism (VTE)
Time frame: within 30 days after study drug administration
Participant-reported quality of life on a proprietary scale
Time frame: Baseline, Day 30 after study drug administration
Number of participants with major or clinically relevant nonmajor bleeding
Time frame: within 30 days after study drug administration
Number of participants re-hospitalized for any reason
Time frame: within 30 days after study drug administration
Number of participants with non-bleeding adverse events (AEs)
Time frame: within 30 days after study drug administration
Number of participants with anti-drug antibodies (ADAs)
Time frame: within 30 days after study drug administration
Plasma concentration of DS-9231
Time frame: Baseline to 30 days after study drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS-9231 in people with Pulmonary Embolism, run by Daiichi Sankyo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in total thrombus volume (time frame: Baseline, 48-96 hours after study drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.