Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    144
  • sponsor
    VectivBio AG
Updated on 11 July 2021
Investigator
Fritze
Primary Contact
Yokohama Municipal Citizen's Hospital (7.8 mi away) Contact
+45 other location

Summary

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Description

This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.

The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.

Details
Condition Short Bowel Syndrome
Treatment apraglutide
Clinical Study IdentifierNCT04627025
SponsorVectivBio AG
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent for this trial prior to any trial specific assessment
Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC)
Subject must require PS at least 3 days per work and be considered stable
No restorative surgery intended to change PS requirements in the trial period
Age 18 years at screening

Exclusion Criteria

Pregnancy or lactation
Major abdominal surgery in the last 6 months prior to screening
History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within 5 years, except for adequately treated basal cell skin cancer
Evidence of active inflammatory GI conditions in the previous 6 months
Evidence of decompensated heart failure
Evidence of severe renal or hepatic impairment
Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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