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Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support

NCT03415594 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-10-26

No results posted yet for this study

Summary

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.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

FE203799 GLP-2 analogue

FE203799 5 mg subQ once weekly

DRUG

FE203799 Placebo GLP-2 analogue

Placebo subQ once weekly

DRUG

FE203799 GLP-2 analogue

FE203799 10 mg subQ once weekly

Sponsors & Collaborators

  • VectivBio AG

    collaborator INDUSTRY

  • GlyPharma Therapeutics

    lead INDUSTRY

Principal Investigators

  • Tomasz Masior · VectivBio AG

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2019-11-21
Completion
2019-11-21

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03415594 on ClinicalTrials.gov