OCT CRO announces the launch of a new international Phase III clinical trial focused on the treatment of iron deficiency anaemia. The study is planned to be conducted in the United States, European countries, India, and China.
This is a multicentre, randomized, active-controlled, open-label clinical study designed to evaluate the efficacy of an investigational intravenous product compared to ferric carboxymaltose in patients with a documented diagnosis of iron deficiency anaemia.
A total of 748 patients are planned to be enrolled worldwide, including 30 patients in Armenia across 5 investigational sites managed by OCT CRO. Submission to the regulatory authorities in Armenia is scheduled for March.
Patients will receive treatment according to their individual iron requirements and in compliance with the applicable prescribing information. The efficacy and safety of the therapy will be assessed during a 6-week follow-up period.
The therapeutic area of the clinical study is hematology. Possible causes of IDA include heavy uterine bleeding, gastrointestinal bleeding, and inflammatory bowel disease. Patient enrolment will be conducted in gynaecology and internal medicine departments.
Within this project, OCT is responsible for the full scope of operational clinical trial services, including monitoring, project management, investigator training, regulatory support, site management, logistics, and quality control.
The launch of this study expands OCT’s portfolio in hematology studies and further demonstrates the company’s expertise in managing international Phase III clinical trials.
