Active — Not RecruitingPhase 3

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

United States, Argentina, Belgium158 participantsStarted 2021-07-13

Plain-language summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013
. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

Exclusion criteria

. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
. Any other reason judged not eligible by the Investigator.
. Pregnancy or lactation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events (AE)

Timeframe: From baseline to week 208

Clinical chemistry

Timeframe: From baseline to week 208

Hematology

Timeframe: From baseline to week 208

Hemostasis

Timeframe: From baseline to week 104

Urinalysis

Timeframe: From baseline to week 208

Occurrence of clinically relevant changes in vital signs

Timeframe: From baseline to week 208

Occurrence of clinically relevant changes in electrocardiogram

Timeframe: From baseline to week 208

Trial details

NCT IDNCT05018286

SponsorVectivBio AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-30

View on ClinicalTrials.gov More Short Bowel Syndrome trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013
. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

Exclusion criteria

. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
. Any other reason judged not eligible by the Investigator.
. Pregnancy or lactation

What they're measuring

Adverse events (AE)

Timeframe: From baseline to week 208

Clinical chemistry

Timeframe: From baseline to week 208

Hematology

Timeframe: From baseline to week 208

Hemostasis

Timeframe: From baseline to week 104

Urinalysis

Timeframe: From baseline to week 208

Occurrence of clinically relevant changes in vital signs

Timeframe: From baseline to week 208

Occurrence of clinically relevant changes in electrocardiogram

Timeframe: From baseline to week 208