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NCT Number: NCT05018286

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Failure Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Fundacion Favaloro, Buenos Aires, Argentina

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About this study

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apraglutide

Drug

Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2

Primary outcomes

  1. Adverse events (AE)

    Time frame: From baseline to week 208

    System organ class, frequency and severity

  2. Clinical chemistry

    Time frame: From baseline to week 208

    Clinical Chemistry panel of analytes will be examined for clinically significant changes.

  3. Hematology

    Time frame: From baseline to week 208

    Hematology panel of analytes will be examined for clinically significant changes.

  4. Hemostasis

    Time frame: From baseline to week 104

    Hemostasis INR will be examined for clinically significant changes.

  5. Urinalysis

    Time frame: From baseline to week 208

    Urinanalysis panel of analytes will be examined for clinically significant changes.

  6. Occurrence of clinically relevant changes in vital signs

    Time frame: From baseline to week 208

    • Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes.
    • Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.

  7. Occurrence of clinically relevant changes in electrocardiogram

    Time frame: From baseline to week 208

    ECG; intervals and rhythm

Secondary outcomes

  1. Change from baseline in PS volume

    Time frame: From baseline to week 208

  2. Change from baseline in PS frequency

    Time frame: From baseline to week 208

    Change in PS days/week from baseline to week 104

  3. Clinically significant changes in PS total energy

    Time frame: From baseline to week 208

    Units: kcal

  4. Change from baseline in PS infusion time

    Time frame: From baseline to week 208

  5. Percentage of subjects reaching enteral autonomy

    Time frame: From baseline to week 104

  6. Change from baseline in body weight

    Time frame: From baseline to week 104

    Units: kg

  7. Change from baseline on the Patient Global Impression of Severity (PGIS)

    Time frame: From baseline to week 104

  8. Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)

    Time frame: From baseline to week 208

  9. Change from baseline on the Patient Global Impression of Change (PGIC)

    Time frame: From baseline to week 208

  10. Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)

    Time frame: From baseline to week 208

  11. Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)

    Time frame: From baseline to week 208

  12. Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)

    Time frame: From baseline to week 208

  13. Change from baseline on the Short Form (36) Health Survey (SF-36)

    Time frame: From baseline to week 208

  14. Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)

    Time frame: From baseline to week 208

Sponsors and collaborators

Lead sponsor

VectivBio AG

Industry

Registry information

Official study title

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

Acronym: STARS extend

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2021
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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