NL-OMON47535
Completed
Not Applicable
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<br>Submassive Pulmonary Embolism. - DS1040-B-U107
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary embolism
- Sponsor
- Daiichi Sankyo, Inc
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 (Heparin) \[LMW (Heparin)] at the time of randomization but for no longer than 36 hours.
- •3\. Able to provide written informed consent.
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 (eg, unfractionated heparin, LMW
- •heparin, Vitamin K antagonists or novel oral anticoagulants) for treatment of the index PE event
- •prior to randomization. Study drug infusion will ideally begin within 6 hours 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 a clinically significant elevated activated partial thromboplastin time (aPTT) that is not explained by use of LMWH;
- •8\. Subjects with active endocarditis;
Outcomes
Primary Outcomes
Not specified
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