Phase 3 extension trial of Glepaglutide in patients with SBS.
Research type
Research Study
Full title
A Double-Blind Phase 3 Extension Trial Assessing the Long-Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
IRAS ID
259180
Contact name
Farooq Rahman
Contact email
Sponsor organisation
Zealand Pharma A/S
Eudract number
2018-001429-26
Clinicaltrials.gov Identifier
133151, IND
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
This double-blind, phase 3 (confirmatory), extension trial assessing the long-term safety and efficacy of glepaglutide in patients with short bowel syndrome (SBS) will provide patients who completed the 24-week treatment period of the lead-in trial (ZP1848-17111) or who completed the phase 2 (exploratory/dose-finding)) ZP1848-15073 trial(not conducted in the UK), the option of long term glepaglutide treatment at a dose regimen of 10 mg twice or once weekly injections.
This extension trial will be conducted at the 5 current sites approved on the lead-in trial.
Patients with short bowel syndrome are often reliant on parenteral support administered via a central line inserted in a vein, due to their reduced intestinal absorption capacity. This treatment affects quality of life and pose certain risks, such as infection from the central line insertion. It was shown in the phase 2 trial, which met its primary efficacy endpoint, that gelpaglutide improves intestinal absorption to a clinically significant degree at dosing levels of 1 mg/day and 10 mg/day.
Patients receiving glepaglutide treatment in this extension trial are likely to experience similar improvements in intestinal function, with reduced dependence on parenteral support as a result.Patients on this study will have to provide informed consent prior to the following assessments and procedures being performed:
- Data collection (demographics, medical history, concomitant illnesses/procedures and medications)
- Vital signs, physical examinations,ECGs and a colonoscopy
- Adverse events collection
- Urine and blood sample collections
- Completing questionnaires and electronic diaries
- Measuring fluid intake, urine and bowel movements or stoma bag emptying over defined 48 hour periods
- Clinic visits (weekly for 1st month, then once in months 2, 3, 6, 9, 15, 18 and 24). Follow up visit about 8 weeks after the end of trial.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0206
Date of REC Opinion
8 May 2019
REC opinion
Favourable Opinion