Regulatory Approval Granted for Chronic Pancreatitis Study in Russia
GCT has successfully obtained Regulatory Approval in Russia for a multinational Phase II randomized double-blind Gastroenterology study. The official approval from the Russian Ministry of Health (MoH) was received on March 20, 2020.
The goal of the study is to evaluate the safety and efficacy of the Investigational Drug compared to placebo in patients with Chronic Pancreatitis. The disease is characterized by inflammation of the pancreas, which worsens gradually and can cause permanent damage. GCT is managing the trial in Russia and Ukraine which is planning on enrolling over 160 patients.
The GCT team is fully operational and continues to support our clients without interruption, despite the COVID-19 pandemic. Currently, we are preparing for the next steps of the study start-up process including Investigational Drug Import License application, Local Ethics Committees submissions, and finalization of clinical trial agreements with sites.
Dr. Selivra, GCT CEO, expresses his gratitude to the team for all their hard work and dedication in achieving this important study milestone during these challenging times.
Updated: April 15, 2020