A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of DS-1040b when Added to Standard of Care Anticoagulation Therapy in Subjects with Acute Submassive Pulmonary Embolism

Daiichi Sankyo, Inc.0 sites116 target enrollmentOctober 4, 2016

ConditionsDS-1040b is an inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) intended to be used for the treatment of thrombotic diseases including Pulmonary Embolism (PE)MedDRA version: 20.0 Level: HLT Classification code 10037379 Term: Pulmonary embolism and thrombosis System Organ Class: 100000004866 MedDRA version: 20.0 Level: PT Classification code 10037377 Term: Pulmonary embolism System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: DS-1040b is an inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) intended to be used for the treatment of thrombotic diseases including Pulmonary Embolism (PE)
Sponsor: Daiichi Sankyo, Inc.
Enrollment: 116
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 4, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Daiichi Sankyo, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Male or female subjects, age 18 to 75 years and body weight between 50 and 130 kg, inclusive;
•2\. Subjects admitted to the hospital with a clinical diagnosis of acute PE with an onset of symptoms in the 5 days prior to diagnosis categorized as low risk or intermediate\-risk or submassive PE and for whom catheter\-based therapy is not planned;
•a. 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;
•b. Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
•c. Subjects may have concurrent DVT and have an inferior vena cava (IVC) filter placed prior to randomization;
•d. Subjects may already be on SOC low molecular weight LMW heparin at the time of randomization but for no longer than 36 hours.
•3\. Able to provide written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\. 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;
•2\. Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
•3\. Subjects with PE lesions only in the sub\-segmental or smaller arteries, which due to limitations of the imaging method may not be consistently identified and measured;
•4\. Subjects unable or unwilling to take the required SOC anticoagulation therapy;
•5\. Subjects receiving more than 36 hours of SOC anticoagulants for treatment of the index PE event prior to randomization. Study drug infusion will ideally begin within 6hr after randomization
•6\. Subjects who had prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, or evidence of active bleeding;
•7\. Subjects with bleeding diathesis, a platelet count \< 100,000, international normalized ratio (INR) \> 1\.7, or clinically significant elevated activated partial thromboplastin time (aPTT) that is not explained by use of LMW heparin;
•8\. Subjects with active endocarditis;
•9\. Subjects with \< 6 month history of acute coronary syndrome (ACS) whether or not they have undergone percutaneous coronary intervention (PCI);
•10\. Subjects who require ongoing dual antiplatelet therapy or treatment with aspirin alone in a dosage of more than 100 mg/per day;