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Sotatercept for Pulmonary Arterial Hypertension(SOTERIA Trial)
SOTERIA Trial Summary
This trial is testing a drug to see if it's safe and effective for treating Pulmonary Arterial Hypertension.
- Pulmonary Arterial Hypertension
SOTERIA Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2022 Phase 3 trial • 324 Patients • NCT04576988
Awards & Highlights
SOTERIA Trial Design
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Who is running the clinical trial?
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
What is the target enrollment for this clinical trial?
"To meet the statistical power required to draw robust conclusions, 700 individuals that fit the study's inclusion criteria will be needed. The trial is being conducted by Acceleron Pharma Inc. at different locations, including Brigham and Womens Hospital in Boston, Massachusetts and Harbor UCLA Medical Center ( Site 1028) in Torrance, California."
To what extent has sotatercept been studied in the past?
"Sotatercept is currently being researched in 4 trials, 3 of which are Phase 3 studies. Even though a large proportion of these clinical trials take place in Edmonton, Alberta, there are 492 research sites for sotatercept across the world"
Is this a pioneering clinical trial?
"Sotatercept has been under investigation since 2021. After the first Phase 3 clinical trial, which was completed in that same year and sponsored by Acceleron Pharma Inc., sotatercept received drug approval. Currently, there are 4 active studies involving sotatercept being conducted in 182 cities across 28 countries."
Are investigators looking for more participants in this experiment?
"Yes, this information is accurate. The trial was first posted on 5/12/2021 and was last updated on 10/28/2022. 37 different locations are needed to enroll the 700 planned participants."
What are some possible adverse effects of sotatercept?
"Sotatercept was given a 3 on our safety scale at Power. This is because sotatercept is in Phase 3 trials, meaning that while there is data supporting efficacy, there are also multiple rounds of data supporting safety."
How many different research facilities are coordinating this study?
"Currently, this clinical trial is taking place in Brigham and Womens Hospital (Boston, MA), Harbor UCLA Medical Center (Torrance, CA), University of Alberta Hospital (Edmonton, AB), as well as 37 other locations."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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