HepNet Study-House
The HepNet Study-House connects individual study centers in the field of hepatitis research and creates a central platform to conduct clinical studies (Investigator Initiated Trials) and build patient cohorts in the field of viral hepatitis. On the one hand, the Study-House is a contact point for scientists and cooperation partners who are interested in conducting a study. On the other hand, it offers Germany-wide networking with practices and doctors who are interested in taking part in a study. The DZIF can use infrastructures and cohorts for its projects. In recent years, many multicenter and international studies have been conducted in the Study-House.
One focus of the HepNet Study-House is on studies and patient cohorts for the treatment of chronic hepatitis delta. The international and multicenter studies on the treatment of chronic hepatitis delta including Interferon carried out in the HepNet Study-House are the largest studies worldwide to date. In addition, the HepNet Study-House has set up an international network–the “Hepatitis Delta International Network” HDIN. All leading scientists in the field of hepatitis delta are now involved in this network and meetings with over 100 people take place twice a year. Between 2011 and 2022, a large international patient database was created in which a total of 2,007 patients from 26 centers in 17 countries were documented. An initial data analysis was published in Liver International in 2017 (to the publication), and a long-term analysis was also published in Liver International in 2024 (to the publication). The HepNet Study-House strives to strengthen cooperation between scientists from the HDIN network.
In addition, the HepNet Study-House supports the establishment of a European cohort with hepatitis delta patients at the MHH. Clinical data from over 1000 patients from 6 European countries were collected and are now being analyzed and published in cooperation with the EU-funded D-SOLVE project.
The HepNet Study-House is currently participating in a biomarker study (BUL-STOP) with hepatitis delta patients who are receiving the drug Hepcludex® (active substance: Bulevirtide), which has been approved since 2020 and was developed within DZIF. In cooperation with the EU-funded D-SOLVE project, 20 patients will have their medication stopped under controlled conditions in order to identify biomarkers for a safe end to therapy. Four study centers in Germany from the DZIF network and one study center in Italy are taking part in the study.
Other main projects in the HepNet Study-House are clinical studies on the treatment of acute hepatitis C (HCV). The HepNet study cohorts of patients with acute hepatitis C are unique worldwide. The acute HCV-IV study was the first to be carried out with official DZIF funding. The acute HCV-V study was carried out from 2019 to 2021, in which 20 patients from 9 different centers in Germany were successfully treated with a direct antiviral drug (DAA). The study manuscript was published in the Journal of Hepatology Reports (to the publication).
In addition to the two main topics of hepatitis delta and acute hepatitis C, the world's first study on the treatment of chronic hepatitis E was carried out in the HepNet Study-House (HepNet pilot trial: Multicenter trial for the treatment of chronic hepatitis E with sofosbuvir (SofE)). The results were published in the Journal of Hepatology in 2020 (to the publication). Samples obtained from this study are used by various working groups in the hepatitis E research area and are published regularly (to the publication). The establishment of a national hepatitis E registry is currently being planned.
Furthermore, the existing hepatitis B patient cohorts of the TTU Hepatitis were expanded as part of a European cooperation in 2021. Extensive data collection in registries is an important tool for improving treatment options and comprehensively characterizing patient populations. The European Hepatitis B Registry was established as a cooperation project between the DZIF and the TherVacB project and has been continuously recruiting new patients from Germany, Spain and Italy since 2021. In addition to its own scientific questions, one goal of the European HBV registry is to support the recruitment of clinical DZIF research projects in a precisely characterized patient population.
Summary
With its clinical studies and patient cohorts, the HepNet Study-House contributes to the development of new therapeutic approaches or the optimization of known therapies.
The successful cooperation between university medicine, research and the pharmaceutical industry makes it possible to carry out large multicenter IIT studies (Investigator Initiated Trials) and to support translational research in the field of viral hepatitis.
