Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassi… (NCT02923115) | Clinical Trial Compass
CompletedPhase 1/2
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
United States134 participantsStarted 2016-06-23
Plain-language summary
This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute pulmonary embolism (PE) categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
* Subjects must have a computed tomography angiography (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 low molecular weight (LMW) 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…
What they're measuring
1
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
Timeframe: Baseline up to Day 30 post infusion, up to approximately 3 years 2 months