A Once-weekly, Repeated Dose, Placebo Controlled, Double Blind, Randomised Cross-over Trial Investigating Safety, Efficacy and Pharmacodynamics of FE 203799 in Patients With Short Bowel Syndrome With Intestinal Failure Requiring Parenteral Support Followed by an Additional Treatment Period in an Open Label Regimen.
Sponsor study identifier
interventional
8
1 country
1
Study Start
May 8, 2018
Actual (reported)Primary Completion
November 21, 2019
Actual (reported)Study Completion
November 21, 2019
Actual (reported)Part A:once weekly dosing for 4 weeks in patients with short bowel syndrome who require total parenteral nutrition; patients will complete period 1 and after a 6-10 week wash-out, they will enter period 2 (active treatment and placebo); Part B: treatment period 3, is an open label extension to part A and starts after a washout of 6-10 weeks after the last dose in treatment period 2. patients are dosed once weekly for 4 weeks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 21, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2017
Actual (reported)January 30, 2018
Actual (reported)May 8, 2018
Actual (reported)November 21, 2019
Actual (reported)November 21, 2019
Actual (reported)Incidence of treatment-emergent adverse events
Adverse events (AEs) as assessed by CTCAE v4.03
Day -28 to Day 29
Assessment of intestinal failure and gut absorption
Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Day -3 - Day 29
Assessment of intestinal failure and gut absorption
Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Day -3 and Day 29
FE203799 GLP-2 analogue, once weekly, subcutaneous administration
Placebo FE203799 GLP-2 analogue, once weekly, subcutaneous administration
FE203799 GLP-2 analogue, once weekly, subcutaneous administration
FE203799 5 mg subQ once weekly
Placebo subQ once weekly
Rigshospitalet
Copenhagen, Denmark
Eliasson J, Hvistendahl MK, Freund N, Bolognani F, Meyer C, Jeppesen PB. Apraglutide, a novel glucagon-like peptide-2 analog, improves fluid absorption in patients with short bowel syndrome intestinal failure: Findings from a placebo-controlled, randomized phase 2 trial. JPEN J Parenter Enteral Nutr. 2022 May;46(4):896-904. doi: 10.1002/jpen.2223. Epub 2021 Sep 7.
Tomasz Masior
VectivBio AG
8 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2017
First Posted
January 30, 2018
Study Start
May 8, 2018
Actual (reported)Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
FE203799 10 mg subQ once weekly
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 21, 2019
Actual (reported)Study Completion
November 21, 2019
Actual (reported)Last Updated
October 26, 2024
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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