Trial · NCT02923115
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
NCT02923115, Phase 1, Phase 2, Completed, Daiichi Sankyo; results first posted 2020-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism. Trials, record NCT02923115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02923115
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
- NCT number
- NCT02923115
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 134 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Pulmonary Embolism, Thrombotic Disease
- Interventions
- DS-1040b, Placebo, Enoxaparin
- First posted
- 2016-10-04
- Last updated
- 2023-04-19
- Other registries' IDs
- eudract:2015-005211-32
- Results first posted
- 2020-07-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Baseline up to Day 30 post infusion, up to approximately 3 years 2 months | Clinically relevant bleeding was defined as major or clinically relevant non-major (CRNM) bleeding adjudicated by the Clinical Events Committee (CEC) based on International Society of Thrombosis and Haemostasis (ISTH) definitions and the CEC charter. |
| Secondary | Mean Percent Change From Baseline in Total Thrombus Volume at 12-72 Hours Post Start of Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Baseline to 12-72 hours post start of infusion, up to approximately 3 years 2 months | The change from baseline in total thrombus volume was assessed by computed tomography angiography in segmental or larger pulmonary arteries following intravenous infusion of DS-1040b or placebo in addition to standard of care anti-coagulation therapy. |
| Secondary | Participants Achieving Reductions in Total Thrombus Volume at 12-72 Hours Post Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Baseline to 12-72 hours post start of infusion, up to approximately 3 years 2 months | Change in total pulmonary thrombus burden (total thrombus volume) was assessed by computed tomography pulmonary angiography (CTPA). All CTPA scans were evaluated by a central imaging laboratory in a blinded manner by radiologists. |
| Secondary | Pharmacokinetic (PK) Parameter Maximum Concentration (CMax) Following Intravenous Infusion of DS-1040b in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusion | Plasma concentrations at each time point and PK parameter Cmax of DS 1040b was calculated using non-compartmental analysis. |
| Secondary | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve (0 to Last) Following Intravenous Infusion of DS-1040b In Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusion | Plasma concentrations at each time point and PK parameter of Area Under the Concentration Versus Time Curve (0 to last) of DS-1040b was calculated using non-compartmental analysis. |
| Secondary | Pharmacokinetic Parameter Terminal Half-life Following Intravenous Infusion of DS-1040b Combined With Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusion | Plasma concentrations at each time point and PK parameter Terminal Half-life of DS-1040b was calculated using non-compartmental analysis. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Baseline up to Day 30 post infusion, up to approximately 3 years 2 months | Adjudicated bleeding events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Percent Change From Baseline in Total Thrombus Volume at 12-72 Hours Post Start of Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Baseline to 12-72 hours post start of infusion, up to approximately 3 years 2 months | Changes in total thrombus volume were assessed in the Efficacy Analysis Set. | percent change | MEAN |
| SECONDARY | Participants Achieving Reductions in Total Thrombus Volume at 12-72 Hours Post Infusion of DS-1040b Compared to Placebo When Added to Standard of Care Anticoagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Baseline to 12-72 hours post start of infusion, up to approximately 3 years 2 months | Reductions in total thrombus volume were assessed in the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic (PK) Parameter Maximum Concentration (CMax) Following Intravenous Infusion of DS-1040b in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusion | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve (0 to Last) Following Intravenous Infusion of DS-1040b In Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusion | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng*h/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter Terminal Half-life Following Intravenous Infusion of DS-1040b Combined With Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: 0 up to 72 h post infusion; Cohorts 2 and 3: 0 up to 96 h post infusion; Cohort 4 and 5: 0 up to 120 h post infusion | Terminal half-life was assessed in patients with available data in the Pharmacokinetic Analysis Set. | hours | MEAN |
Source ClinicalTrials.gov
Results by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: DS-1040b 20 mg | At least 1 bleeding event | 4 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 2: DS-1040b 40 mg | At least 1 bleeding event | 3 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 3: DS-1040b 60 mg | At least 1 bleeding event | 3 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 4: DS-1040b 80 mg | At least 1 bleeding event | 4 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 5: DS-1040b 40 mg | At least 1 bleeding event | 1 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Placebo | At least 1 bleeding event | 10 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 1: DS-1040b 20 mg | Major bleeding event | 0 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 2: DS-1040b 40 mg | Major bleeding event | 0 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 3: DS-1040b 60 mg | Major bleeding event | 0 | Participants | |
Number of Participants Experiencing Adjudicated Clinically Relevant Bleeding Events Following Intravenous Infusion of DS-1040b or Placebo in Addition to Standard of Care Anti-coagulation Therapy in Participants With Acute Submassive Pulmonary Embolism | Cohort 4: DS-1040b 80 mg | Major bleeding event | 1 | Participants |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: DS-1040b 20 mg | 12 | |
| Overall Study | STARTED | Cohort 2: DS-1040b 40 mg | 16 | |
| Overall Study | STARTED | Cohort 3: DS-1040b 60 mg | 23 | |
| Overall Study | STARTED | Cohort 4: DS-1040b 80 mg | 23 | |
| Overall Study | STARTED | Cohort 5: DS-1040b 40 mg | 22 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | Treated | Cohort 1: DS-1040b 20 mg | 12 | |
| Overall Study | Treated | Cohort 2: DS-1040b 40 mg | 16 | |
| Overall Study | Treated | Cohort 3: DS-1040b 60 mg | 20 | |
| Overall Study | Treated | Cohort 4: DS-1040b 80 mg | 22 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events744
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Cohort 1: DS-1040b 20 mg | 2 | 12 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Cohort 2: DS-1040b 40 mg | 2 | 16 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Cohort 3: DS-1040b 60 mg | 2 | 20 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Cohort 4: DS-1040b 80 mg | 0 | 22 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Cohort 5: DS-1040b 40 mg | 0 | 17 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 3 | 38 | |
| other | Headache | Nervous system disorders | Cohort 1: DS-1040b 20 mg | 1 | 12 | |
| other | Headache | Nervous system disorders | Cohort 2: DS-1040b 40 mg | 0 | 16 | |
| other | Headache | Nervous system disorders | Cohort 3: DS-1040b 60 mg | 3 | 20 | |
| other | Headache | Nervous system disorders | Cohort 4: DS-1040b 80 mg | 2 | 22 |
1 to 10 of 744Source ClinicalTrials.gov
See all 744 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: DS-1040b 20 mg | 0 | 12 |
| Total, all-cause mortality | Cohort 2: DS-1040b 40 mg | 0 | 16 |
| Total, all-cause mortality | Cohort 3: DS-1040b 60 mg | 0 | 20 |
| Total, all-cause mortality | Cohort 4: DS-1040b 80 mg | 0 | 22 |
| Total, all-cause mortality | Cohort 5: DS-1040b 40 mg | 0 | 17 |
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, other adverse events | Cohort 1: DS-1040b 20 mg | 8 | 12 |
| Total, other adverse events | Cohort 2: DS-1040b 40 mg | 6 | 16 |
| Total, other adverse events | Cohort 3: DS-1040b 60 mg | 13 | 20 |
| Total, other adverse events | Cohort 4: DS-1040b 80 mg | 10 | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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