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.
Phase of Trial: Phase II
Latest Information Update: 25 Jan 2019
At a glance
- Drugs Apraglutide (Primary)
- Indications Short bowel syndrome
- Focus Adverse reactions
- Sponsors GLyPharma Therapeutic; Therachon
- 17 Jan 2019 A new treatment period 3 (Part B) has been added in study and it is an open label extension to part A that will test a new dose and dose for FE203799 Part A has also changed from 25mg to 5 mg.
- 17 Jan 2019 Planned End Date changed from 1 Apr 2019 to 1 Sep 2019.
- 17 Jan 2019 Planned primary completion date changed from 1 Mar 2019 to 1 Aug 2019.