04.Apr.2012

OCT starts a Phase 2a multinational clinical trial in hepatitis B virus infection

OCT has been awarded a Phase 2a multinational, randomized, open-label clinical trial of daily administration of investigational drug versus standard of treatment in patients with HBeAg negative chronic hepatitis B virus infection

OCT has been awarded a Phase 2a multinational, randomized, open-label clinical trial of daily administration of investigational drug versus standard of treatment in patients with HBeAg negative chronic hepatitis B virus infection. The client is a new Russian biotech company specialized in liver diseases and backed by Russian and foreign venture capital.

The investigational drug candidate could potentially be used for treatment of chronic hepatitis B (CHB) and chronic hepatitis D (CHD). The drug's unique mechanism of action offers the possibility to address the two most important medical needs, namely long-term HBV (hepatitis B virus) eradiation as well as antiviral activity against hepatitis delta virus (HDV). The main goal of the novel treatment approach will be to reduce HBsAg levels in serum of the patients.

The clinical study will be placed in Russia and Ukraine and involve 4 sites enrolling 32 patients within 8 months. The total study duration is estimated as 21 months, including data management and final statistical report.

OCT will provide full-service assistance starting from regulatory documents preparation and support, e-CRF development and data base setup, sites selection and start-up, project managementand clinical monitoring, up to safety management, quality assurance, vendors' management, interim analysis, WRS, final report preparation. Leading European PK, immunology, and virology laboratories will be included into the study to provide biological samples analysis support.

In Russia HBV vaccination was included into the National Immunization Schedule in 2001. Since then all newborn infants are vaccinated thrice. Since 2006 vaccination in adults started in Russia as well. By the present moment around 46 million people have been inoculated against hepatitis B virus, and more than a million are suffering from chronic hepatitis B in the country.

According to the WHO, the total population of chronic hepatitis B patients exceeds 1 billion globally. According to European experts' information, more than 2 billion people are infected by hepatitis B virus worldwide.

In Russia the popularity of hepatitis B antigen carriers is variable: less than 1 % in the European part of the country, 4-5% in the Eastern Siberia, 8-10% in the Northern Caucasus, Yakutia, and Tyva. In highly endemic regions the hepatitis B incidence rate comes up to 120-280 per 100 000. Nowadays the hepatitis B incidence is around 35,8 in Russia. Together with HIV and hepatitis C, hepatitis B is one of the most dangerous viral parenteral infections resulting in human average lifetime decrease globally.