What is SBS-IF and Parenteral Support?

SBS-IF stands for short bowel syndrome with intestinal failure. People with SBS-IF are missing parts of their small intestine or colon mainly due to surgical removal of the intestine or the colon. Common causes of SBS-IF include:

inflammatory bowel disease such as Crohn's
lack of blood flow into the intestine
trauma
complications due to cancer

With SBS-IF, the body can no longer maintain hydration or ability to absorb fluids or nutrition on its own. To maintain life, patients need artificial nutrition, known as parenteral support.

Parenteral support includes intravenous (IV) fluids and artificial nutritional formulation that comes in a bag. Parenteral support (PS) can also be referred to as parenteral nutrition (PN) or total parenteral nutrition (TPN).

Why should I participate?

There are significant burdens that SBS-IF patients have when they need to live with their parenteral support. While it can be lifesaving, it can also significantly impact quality of life. By enrolling in this Phase 3 study, you may potentially see improved bowel (gut) function with better absorption of fluids and nutrition that leads to:

Reduction in the amount of parenteral support (TPN, IV fluids, or electrolytes) needed
Complete elimination of parenteral support (TPN, IV fluids, or electrolytes)
Improvements in quality of life such as less sleep disruption and reduced pain
Less diarrhea or less output from stoma bag in patients with an ostomy

Can I participate?

You may be able to participate in the STARS clinical trial if you:

Are 18 years of age or older

Have diagnosis of SBS-IF

Require 3 or more days a week of parenteral support such as TPN, IV fluids, or electrolytes

Receive parenteral support such as TPN, IV fluids, or electrolytes for more than 6 months

Other eligibility criteria may apply.
See If I May Qualify

We know that every individual has a different experience with their SBS. By participating in this study, you will be seen by SBS experts and could receive specialized care for your SBS with the goal of improving overall gut function.

What you may receive

Study related care at no cost
Study related medical care related to short bowel syndrome with intestinal failure
Travel, lodging, and meal reimbursements for clinic visits
Home trial visits with a nurse

What is the purpose of the STARS study?

The purpose of this study is to evaluate how the study drug, apraglutide*, may help patients with SBS better manage their symptoms and may decrease the amount of PS needed as a result of improved gut health.

*Apraglutide is an investigational medicinal product that is not registered in any country.

What’s involved?

1. Application

Click here to see if you may qualify.

2. Phone Call

Upon initial eligibility, a patient outreach representative will call you and help guide you through additional eligibility questions.

3. Official Screening

The team at a participating study center will determine if you are eligible to participate in the study and what would be required for participation.

4. Study

Throughout the study, you will take the study medication weekly and have a mix of virtual and in-person visits, depending on your needs. You will be asked to keep a diary to record specific experiences and answer questions about your experience living with SBS-IF.

Frequently Asked Questions

How do I get started?

Click See if you may qualify and enter your information to express interest in the study.

What is the study drug being tested? How does it work?

The study drug, apraglutide, is a GLP-2 medication. GLP-2 medications, called GLP-2 analogs, have been developed to improve the function of your remaining intestine.  GLP-2 helps people properly absorb fluids and nutrients to maintain a healthy life.  Apraglutide* is being studied as a once-weekly injection.

*Apraglutide is an investigational medicinal product that is not registered in any country.

Has the study drug been tested before?

The study drug has been previously tested in earlier smaller clinical trials to determine if the investigational drug helped increase fluid and nutrient absorption in SBS patients and was safe to proceed to this larger study.

How does the study drug compare to other drugs for SBS-IF?

Unlike the other approved treatment which is injected daily, the study drug is injected once a week.

Do I need health insurance?

No, health insurance is not needed in order to participate.

What side effects should I expect?

Common side effects may include skin irritations near injection site, nausea, abdominal pain, and increased amount of urine. An increase in absorption of fluids may lead to swelling in the abdomen, legs or arms.

Is there any cost for me to participate?

There is no cost to you or your insurance provider for participating in the trial. If you qualify for the trial, you may be reimbursed for your travel expenses.

Can I leave the study at any time?

You’re free to withdraw from the study at any time. If and when you sign up, your participation is completely voluntary.

Why didn’t I qualify?

Research studies are designed in specific ways to test the study drug for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this trial. This does not mean you will not qualify for different research studies.

How will the study therapy be taken?

Study therapy (apraglutide or placebo) is administered under the skin once a week via injection, ideally on the same day of the week and at the same time of day.

How long will the study take place?

The study may last up to 63 weeks.

Will I have access to the study medication after the study ends?

If you agree and are eligible, you may be able to participate in an extension trial and continue to receive the study medication.

I'm Interested

About The Sponsor

VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development and commercialization of innovative treatments for severe rare conditions with high unmet medical need. The company is committed to pursuing severe rare diseases with well-defined biology that can be targeted with therapies tailored to patients’ needs. They are headquartered in Basel, Switzerland, with business operations in the New York area.

Stay Updated

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Back
to Top
See If I May Qualify