Background: Hepatitis D is a worldwide health problem. Hepatitis D is not as common as hepatitis B and C, but has a more aggressive course of disease and leads more quickly and frequently to cirrhosis and primary liver cancer. Smooth Drug Development participated in a clinical research program in Hepatitis D of an innovative drug for the treatment of chronic hepatitis delta in combination with an immunomodulator with antiviral effect.
About a trial: Our responsibility of the study was to develop medical documentation, regulatory support, monitoring centers. The study took place on the territory of EAEU.
Challenges: In many countries hepatitis delta is considered an orphan disease and there was no experience in conducting clinical trials for this disease anywhere in the world. During the site selection, we were faced with lack of experience in conducting hepatitis D trials by medical organizations in EAEU, so we conducted a thorough selection of centers that had experience in conducting trials in other nosologies and conducted thorough training on the protocol. We included 7 centers and recruited 60 patients on time.