20.Jul.2012

OCT is going to perform a Data Base lock for a HBV trial

OCT is going to perform a Data Base lock for a HBV trial. This was a phase I trial performed at I site in Germany. OCT was awarded with the trial by a German biotech company which is developing its drug candidate aimed at the treatment of chronic viral hepatitis B and D.

OCT is going to perform a Data Base lock for a HBV trial. This was a phase I trial performed at I site in Germany. OCT was awarded with the trial by a German biotech company which is developing its drug candidate aimed at the treatment of chronic viral hepatitis B and D.

OCT was responsible for Data Management and statistics in the trial. OCT provided the client with an electronic CRF. Web-based process implies that data is entered directly from the study sites into electronic CRFs (e-CRFs). Error checking during data entry at the sites allows early detection and correction of errors including direct checking against source documents. Within this trial we performed the following activities:

  • Drafting, Revision, and Finalization of Data Management Plan
  • Design and Build of Database
  • eCRF Review and Validation
  • Process and Resolve Queries
  • External Data Integration
  • Coding of Medical Terms
  • Data Quality, Database Audits and Database Archive
  • Statistical Analysis Plan and Tables/Listings/Figures Specifications
  • Statistical Programming and Quality Control
  • Statistical report

At the moment OCT is initiating a subsequent phase II clinical trial for the same company in Russia.

It is well documented that the prevalence of HBV (hepatitis B) infection in the world is very high: about 2 billion people are carriers of HBV, of which about 350 million are chronically ill. In some 5% of individuals with chronic hepatitis B virus the presence of hepatitis D is revealed. Such co-infection results in more severe and rapid progression to liver disease. Currently there is no drug approved to treat patients with hepatitis D.

The lead compound blocks the penetration of Hepatitis B and D viruses into hepatocytes (liver cells). By treating with an entry inhibitor, new infection of constantly-evolving, healthy hepatocytes may be blocked and the number of infected cells should significantly decline within a few months. The immune system could then regain control over the infection and long-term treatment with viral replication inhibitors omitted or significantly shortened.