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Glucagon-like peptide-2 (GLP-2) receptor agonist
Apraglutide for Short Bowel Syndrome (STARS Trial)
Phase 3
Waitlist Available
Research Sponsored by VectivBio AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 / 24 / 48 of treatment
Awards & highlights
STARS Trial Summary
This trial is testing if apraglutide is effective in reducing the need for parenteral support (getting nutrients through an IV).
Who is the study for?
This trial is for adults over 18 with Short Bowel Syndrome-Intestinal Failure who need parenteral support at least 3 days a week and are stable. They shouldn't plan any restorative gut surgery during the trial, have had recent major abdominal surgery, inflammatory GI conditions, severe organ impairment, or cancer within the last 5 years.Check my eligibility
What is being tested?
The trial tests apraglutide's effectiveness in reducing dependency on parenteral support (PS) among patients with SBS-IF. Participants will receive weekly subcutaneous injections of apraglutide to see if it can help reduce their need for PS.See study design
What are the potential side effects?
While specific side effects of apraglutide aren't listed here, similar medications often cause digestive issues like nausea or diarrhea, injection site reactions, and potential changes in blood sugar levels.
STARS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 12 / 24 / 48 of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 / 24 / 48 of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relative change from baseline in actual weekly PS volume at Week 24.
Secondary outcome measures
Absorption rate constant (ka) of apraglutide through population PK data analysis
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
+12 moreSTARS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Apraglutide SC injections, once weeklyExperimental Treatment1 Intervention
Peptide analogue of GLP-2
Group II: PlaceboPlacebo Group1 Intervention
Placebo for apraglutide, SC injection once weekly
Find a Location
Who is running the clinical trial?
VectivBio AGLead Sponsor
10 Previous Clinical Trials
322 Total Patients Enrolled
4 Trials studying Short Bowel Syndrome
183 Patients Enrolled for Short Bowel Syndrome
BolognaniStudy DirectorVectivBio AG
5 Previous Clinical Trials
259 Total Patients Enrolled
2 Trials studying Short Bowel Syndrome
167 Patients Enrolled for Short Bowel Syndrome
SeabrookStudy DirectorVectivBio AG
2 Previous Clinical Trials
167 Total Patients Enrolled
2 Trials studying Short Bowel Syndrome
167 Patients Enrolled for Short Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a flare up of inflammatory bowel disease or other gastrointestinal conditions in the past 6 months.If you have ever used growth hormones or similar medications before, you will need to talk with the researcher before joining the study.You have severe heart failure that is not stable.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Apraglutide SC injections, once weekly
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many different medical facilities are participating in this research project?
"Mount Sinai Medical Center in New york, New York, University of Washington Medical Center in Seattle, Washington, and Duke University Hospital in Durham, North carolina are a few of the many places where this clinical trial is taking place."
Answered by AI
Has the FDA given apraglutide the green light?
"There is reliable evidence to support the efficacy of apraglutide, as it has progressed to a Phase 3 trial. Furthermore, multiple rounds of data have been collected to support its safety, so it receives a score of 3."
Answered by AI
How many willing participants are there for this experiment?
"The listing on clinicaltrials.gov says that this trial is currently enrolling patients. The study was first announced on January 26th, 2021 and the most recent update was on June 1st, 2022. A total of 144 people are needed at 17 different hospitals or clinics."
Answered by AI
Are new participants being enrolled in this experiment at this time?
"The recruitment status of this clinical trial can be found on clinicaltrials.gov. This trial was posted on 1/26/2021 and was last edited on 6/1/2022."
Answered by AI
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