GCT has been awarded a new clinical trial in Ukraine and Russia.
A Phase II multinational study in subjects with Idiopathic Pulmonary Fibrosis
(IPF) is designed to investigate the safety, efficacy, and pharmacokinetics of
the investigational product. IPF is a disease that is characterized by scarring
of the lungs. As condition develops, it becomes harder and harder to breathe.
There’s no cure for this disease, however medications can help manage the
symptoms.
We are providing full-service clinical support in both countries, including feasibility analysis and site identification, regulatory support, monitoring, site management and financial management. The trial is currently in the start-up stage in Ukraine and Russia. Regulatory submission preparations and pre-study visits to the selected sites are in progress.
“Idiopathic Pulmonary Fibrosis is a serious and devastating
disease, often with poor prognosis. We look forward to conducting this
important trial aimed at improvement of patients’ quality of life. It enhances
our extensive experience in rare diseases and, ultimately, will provide
patients with more treatment options,” – Dr. Jeffrey Apter, GCT President.