Active not recruitingPHASE3INTERVENTIONAL

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

This study is an extension of previous research, designed to check the long-term effects of a treatment called apraglutide. It's for adults with Short Bowel Syndrome (SBS), a condition where part of the small intestine is missing or doesn't work properly. The main goal is to see how safe and well-tolerated apraglutide is when taken once a week for a longer time, up to four years, or until it becomes widely available. By extending the study, researchers hope to gather more information about its safety, how well it works, and if its benefits last over time. Only people who have already taken part in specific previous apraglutide studies (TA799-007 or TA799-013) can join.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

VectivBio AG

Enrolment target

158

Start

13 Jul 2021

Estimated completion

30 Oct 2027

Short Bowel Syndrome

What is this study about?

This research is an ongoing study looking at a medicine called apraglutide for people who have Short Bowel Syndrome (SBS). SBS is a difficult condition where your body struggles to absorb enough nutrients and fluids because a part of your small intestine is missing or not working as it should. This study is an 'open-label extension', which means that both you and your doctors will know you are receiving apraglutide. This is different from some studies where people might get a dummy treatment.

The main aim of this study is to gather more information about how safe apraglutide is when used over a longer period, up to four years. Researchers also want to see how well people tolerate the treatment, if it continues to work effectively, and if the benefits last over time. This information is really important for understanding the full picture of how apraglutide could help people with SBS in the long run.

Only people who have already been part of two specific earlier studies (called TA799-007 or TA799-013) can join this extension study. This helps researchers track the same group of people over many years to see the long-term effects of the treatment. The findings from this study will add valuable knowledge to help doctors and patients make informed decisions about managing Short Bowel Syndrome.

Key takeaways

This study evaluates the long-term safety and effects of apraglutide for Short Bowel Syndrome.
It's an extension for people who were in previous apraglutide studies (TA799-007 or TA799-013).
The study aims to observe safety and benefits of the treatment over up to four years.
Participants will receive weekly apraglutide doses.
Regular health check-ups will be part of the study.

Who may be eligible?

To be able to join this study, you must be an adult (aged 18 or older) with Short Bowel Syndrome. You must also have been a participant in one of two specific previous studies concerning apraglutide, known as TA799-007 or TA799-013. This ensures that the researchers are tracking people who have already had some experience with the treatment.

It's important that you are able to understand what is involved in the study and are willing to follow all the instructions, including attending regular appointments. You also can't be pregnant or breastfeeding if you wish to participate. The study team will review all aspects of your health and situation to make sure the study is a good fit for you and that it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Short Bowel Syndrome?
Did you participate in one of the previous apraglutide studies (TA799-007 or TA799-013)?
Are you able to attend regular study appointments and follow instructions?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will continue to receive the study medicine, apraglutide, once a week. The study could last for up to four years (208 weeks), or until apraglutide becomes generally available in your country, whichever happens first. Throughout this time, you'll have regular visits to the clinic so the study team can monitor your health and how you're responding to the treatment. These visits will involve various checks, which might include blood tests, physical examinations, and discussions about how you're feeling and any side effects you might be experiencing. The specific schedule of these visits and assessments will be explained in detail by the study staff.

Potential risks and benefits

Participating in this study might offer a chance to continue receiving apraglutide, which could help manage your Short Bowel Syndrome over a longer period. This could provide ongoing benefits for your health and quality of life. However, as with any medicine, there's always a chance of side effects, some of which might be unpleasant or unexpected. The study team will monitor you closely for any issues that arise. It's really important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

Ronald Reagan UCLA Medical Center
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Los Angeles, United States
Gastroenterology Group of Naples
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Naples, United States
Northwestern University - Chicago
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Chicago, United States
Henry Ford Health System
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Detroit, United States
Mayo Clinic - Rochester
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Rochester, United States
University of Nebraska Medical Center
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Omaha, United States
Mount Sinai Medical Center
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New York, United States
Duke University Medical Center
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Durham, United States
Cincinnati Children's Hospital Medical Center
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Cincinnati, United States
Cleveland Clinic Foundation
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Cleveland, United States
Hospital of the University of Pennsylvania
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Philadelphia, United States
Vanderbilt University Medical Center
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Nashville, United States

Common questions

What is Short Bowel Syndrome (SBS)?

SBS is a condition where your body can't absorb enough nutrients because a significant part of your small intestine is missing or not working properly.

What is apraglutide?

Apraglutide is a medicine being studied to help people with Short Bowel Syndrome.

Why is this study only for people from previous trials?

This study is an 'extension' to learn more about the long-term effects on people who have already received apraglutide in earlier studies.

How long will I be in the study if I join?

You could be in the study for up to four years (208 weeks), or until apraglutide is widely available in your country.

Do I have to pay to be in the study?

No, you will not have to pay for the study medicine or related study procedures.