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Long-Term Safety of Apraglutide for Short Bowel Syndrome (STARS extend Trial)
STARS extend Trial Summary
This trial tests a drug to see if it's safe and if people with short bowel syndrome can tolerate it in the long-term.
STARS extend Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTARS extend Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 trial • 16 Patients • NCT04699032STARS extend Trial Design
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Who is running the clinical trial?
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- I was part of previous trials TA799-007 or TA799-013 and have SBS-IF due to surgery on my small intestine.I understand and agree to follow the trial's schedule and requirements.
- Group 1: Apraglutide subcutaneous (SC) injections, once weekly
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any regulatory endorsements for the weekly subcutaneous application of Apraglutide?
"Although this is a Phase 3 clinical trial, there exists substantial evidence of apraglutide subcutaneous (SC) injections efficacy and safety, earning it a score of 3."
Are there any openings to participate in this experiment at present?
"Affirmative. According to the clinicaltrials.gov database, this investigation is in a state of active recruitment. This study was initially made available on July 13th 2021 and underwent its most recent update on June 14th 2023. A total of 138 patients need to be enrolled across 38 sites for completion of the trial."
Are there numerous medical centers participating in this trial across the United States?
"This clinical trial has a total of 38 locations, including the University of Nebraska Medical Center in Omaha, Mount Sinai Medical Center in New york, and Duke University Medical Centre in Durham."
What is the intake capacity for this clinical trial?
"With a total of 138 participants, VectivBio AG's clinical trial will be conducted across multiple sites including the University of Nebraska Medical Center (Omaha) and Mount Sinai Medical Center (New york City). All those recruited must meet the study inclusion criteria."
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