PB2452 in Ticagrelor-treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure
-
- STATUS
- Recruiting
-
- participants needed
- 200
-
- sponsor
- PhaseBio Pharmaceuticals Inc.
Summary
This is a multi-center, open-label, prospective single-arm study of reversal of the
antiplatelet effects of
Approximately 200 patients will be enrolled at approximately 200 centers worldwide. Patients
with reported use of
Description
The study will consist of a Screening/Pre-treatment period, an on-site assignment to study
treatment and administration, a Follow-up visit on (Day 3 and Day 7) and a Final Follow-up
visit (Day 35).
On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria
will receive an intravenous (IV)
In subjects with potential
All subjects may be discharged from the clinical site between Days 3 and 7 inclusive and will return for a Follow-up visit on Day 7, if already discharged, and on Day 35 ( 3 days).
Details
Condition |
|
---|---|
Age | 18years - 100years |
Treatment |
PB2452 |
Clinical Study Identifier | NCT04286438 |
Sponsor | PhaseBio Pharmaceuticals Inc. |
Last Modified on | 19 February 2024 |
How to participate?
,
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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