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Randomized Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923115
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE June 23, 2016
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
Number of participants with clinically relevant bleeding [ Time Frame: baseline (Day 0) to Day 30 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
Rate of adjudicated clinically relevant bleeding, compared to placebo [ Time Frame: baseline Day 0 to Day 30 ]
To assess the safety and tolerability of ascending doses of DS-1040b given as a single intravenous (IV) infusion, when added to standard of care (SOC) anticoagulation therapy, by evaluating the rate of adjudicated clinically relevant bleeding, compared to placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Change from baseline in pulmonary embolism PE thrombus volume [ Time Frame: baseline (Day 0) to Day 30 ]
  • Number of serious adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  • Severity of serious adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  • Number of treatment emergent adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  • Severity of treatment emergent adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  • Area Under the Concentration Curve (AUC) for DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]
  • Terminal elimination half-life (t1/2) of DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]
  • Maximum concentration (Cmax) of DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]
  • Time of maximum concentration (Tmax) for DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Pulmonary embolism PE thrombus volume reduction [ Time Frame: baseline Day 0 to Day 30 ]
    PE thrombus volume reduction from baseline to end of study drug administration assessed via CT pulmonary angiography
  • Number and severity of serious adverse events [ Time Frame: baseline Day 0 to Day 30 ]
    Overall safety evaluation (serious adverse events [SAEs], treatment-emergent adverse events [TEAEs], clinical laboratory parameters
  • Number and severity of treatment emergent adverse events [ Time Frame: baseline Day 0 to Day 30 ]
    Overall safety evaluation (serious adverse events [SAEs], treatment-emergent adverse events [TEAEs], clinical laboratory parameters
  • Number and severity of clinical laboratory abnormalities [ Time Frame: baseline Day 0 to Day 30 ]
    Overall safety evaluation (serious adverse events [SAEs], treatment-emergent adverse events [TEAEs], clinical laboratory parameters
  • Area Under the Concentration Curve (AUC) [ Time Frame: baseline Day 0 to Day 30 ]
    Pharmacokinetics (PK) of DS-1040b in subjects with PE
  • Terminal elimination half-life (t1/2) [ Time Frame: baseline Day 0 to Day 30 ]
    Pharmacokinetics (PK) of DS-1040b in subjects with PE
  • Maximum concentration (Cmax) [ Time Frame: baseline Day 0 to Day 30 ]
    Pharmacokinetics (PK) of DS-1040b in subjects with PE
  • Time of maximum concentration (Tmax) [ Time Frame: baseline Day 0 to Day 30 ]
    Pharmacokinetics (PK) of DS-1040b in subjects with PE
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
Official Title  ICMJE A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b When Added to Standard of Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism
Brief Summary This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic Research Organization ARO and Clinical Research Organization CRO blinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in subjects with acute submassive pulmonary embolism.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Embolism
  • Thrombotic Disease
Intervention  ICMJE
  • Drug: DS-1040b
    injection
  • Drug: placebo
    0.9% Sodium Chloride Injection
Study Arms  ICMJE
  • Experimental: DS-1040b
    9 subjects each in Cohorts 1 and 2, and 15 subjects each in Cohorts 3, 4, 5, and 6.
    Intervention: Drug: DS-1040b
  • Placebo Comparator: placebo

    9 subjects each in Cohorts 1 and 2, and 5 subjects each in Cohorts 3, 4, 5, and 6.

    0.9% Sodium Chloride Injection

    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2019)
134
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2016)
132
Actual Study Completion Date  ICMJE August 5, 2019
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute PE categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
  • Subjects must have a CTA scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
  • Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
  • Subjects must be able to provide written informed consent.

Exclusion Criteria:

  • Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation;
  • Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
  • Subjects with PE lesions only in the sub-segmental or smaller arteries;
  • Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with LMW(low molecular weight Heparin) in therapeutic doses prior to randomization;
  • Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding;
  • Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;
  • Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding;
  • Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
  • Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02923115
Other Study ID Numbers  ICMJE DS1040-B-U107
2015-005211-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Study Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP