At the end of April 2012, OCT clinical team prepared documents required for regulatory and ethics submission for a Phase Ib/IIa multinational, randomized, open-label clinical trial of daily administration of the investigational drug versus standard of treatment in patients with HBeAg negative chronic hepatitis B virus infection.
The following list of documents has been submitted to the Russian Ministry of Healthcare and Social Development by OCT in order to obtain clinical trial approval: the letter of application; the application form; the power of attorney; the final study protocol; the informed consent form and patient’s information sheet; the insurance agreement for 36 patients; information regarding any compensation for patients; the investigator’s brochure; the list of trial sites; PIs’ CVs and statements of compliance with the study protocol signed by investigators; the document confirming state fee payment; information letter confirming relations between Russian biotech (licensee) and German licenser (developer) and cGMP contract manufacturer.
This study is designed to investigate changes in HBsAg level affected by IND treatment; to assess safety and tolerability, the virological response (HBV DNA level), the biochemical response, PK profile and immunogenicity of the investigational drug.
There will be a 12-week treatment period and a 12-week follow-up period. On receiving the results on viral load and evaluating clinical and biochemical picture of the disease, all the patients will continue their treatment in accordance with the applicable standards.
The study drug has been tested previously in pre-clinical research (mice, rats, dogs, chimpanzee) and a phase I trial in 24 healthy volunteers in the EU. Study drug efficacy in reducing activity of Hepatitis B viral, no cytotoxicity and no lethal outcomes have been demonstrated within early stage research.
The clinical study will be placed in Russia and Ukraine and enroll 32 subjects at 8 sites. Recruitment is to be initiated in August 2012 and ended in December 2012; the clinical trial closure is planned in December 2013. OCT will perform full-service clinical trial support and hope to continue its strategic collaboration with the Sponsor within other clinical research projects.