A multicentre open-label phase IIa study with escalating dose of MS1819-SD, to investigate the efficacy and safety of a Yarrowia lipolytica lipase preparation for the compensation of exocrine pancreatic insufficiency caused by chronic pancreatitis and/or distal pancreatectomy.
Phase of Trial: Phase II
Latest Information Update: 27 Feb 2018
At a glance
- Drugs Lipase (Primary)
- Indications Exocrine pancreatic insufficiency; Pancreatitis
- Focus Adverse reactions
- Acronyms MS1819-SD
- 27 Feb 2018 Planned number of patients changed from 15 to 13.
- 12 Feb 2018 According to an AzurRx BioPharma media release, company has enrolled three new patients in the trial and expects to complete enrollment in the first half of 2018.
- 18 Jan 2018 According to an AzurRx BioPharma media release, the company has received the required approvals including Ethics Committee and the French Regulatory Agency (ANSM) to add a French site, the Hopital Latimone in Marseille to this trial.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History