Hepatitis D phase III study
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 trial of an innovative drug for the treatment of chronic hepatitis.
About a trial: Smooth Drug Development was responsible for the planning of the entire clinical trial. In this international study, we handled the development of medical documentation, regulatory support, center monitoring, and logistics, including importing the drug from Germany and exporting biological samples. The study was conducted in 2 countries, EAEU and Germany, in 15 centers where were enrolled 120 patients.
Challenges: Initially, the study started only in EAEU, but later it was decided to expand the geography and conduct the study in Germany as well. Despite the different costs of living in these countries, the sponsor wanted to keep the grant to the investigators at the level of the EAEU region. Many sites in Germany were interested in participating in the study because of its scientific novelty, and we were able to include the necessary number of medical organizations. In this project, our sites successfully passed the EMA inspection.
Based on the results of the clinical trial, the drug was registered on EU and EAEU. The organization that developed the drug was bought by a global pharmaceutical company for more than 1 billion euros. The drug is in the process of registration by FDA.