Clinical Research Organization

crobangladesh@gmail.com

 +8801819251514

Clinical Trial of Recombinant Erythropoietin

Erythropoietin is a glycoprotein hormone that plays key role in formation of red blood cells. Recombinant Erythropoietin was synthesized in genetically engineered Chinese hamster ovary (CHO) cells for the first time in Bangladesh by Globe Biotech Ltd. 

A randomized, double-blinded, active controlled, single dosing, crossover clinical trial to investigate the pharmacokinetics, pharmacodynamics and safety of Recombinant Erythropoietin and Eprex, manufactured by Janssen Cilag Ltd., UK after subcutaneous administration in healthy adult volunteers was conducted by CRO Ltd.

The clinical trial was sponsored by Globe Biotech Ltd. The trial was monitored by Directorate General of Drug Administration, Bangladesh. It is now commercialized in Bangladesh as GBpoietin and is indicated for chronic kidney disease in patients on dialysis and not on dialysis, in HIV-infected patients on Zidovudine, to counter effects of  concomitant myelosuppressive chemotherapy, to reduce allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery and prevention of anemia of premature infants.