HepNet Study-House
The HepNet Study-House connects individual trial centres in the hepatitis research field, creating a central platform for conducting clinical trials (investigator initiated trials). In addition, it establishes patient cohorts for viral hepatitis research. On the one hand, the Study-House is a point of contact for scientists and collaboration partners who are interested in conducting trials. On the other hand, it offers a nationwide network to include practices and doctors in Germany who are also interested in participating in trials. The DZIF can use these networks and cohorts for its projects. Over the last few years, several multicentre and international trials have been conducted.
The most significant projects at the HepNet Study-House include clinical trials on acute hepatitis C (HCV) treatment. The HepNet trial cohorts of patients with acute hepatitis C are globally unique. The acute HCV IV trial was the first to be conducted with official DZIF funding. In this trial, patients with acute HCV infections were treated with the new interferon-free therapy for the first time worldwide. In 2019, the HepNet aHCV-V study has started, which has also been made possible with DZIF funds. First results will be presented at congresses in 2022.
The Study House also focuses on trials and patient cohorts for the treatment of chronic hepatitis D. International and multicentre trials on the treatment of chronic hepatitis D conducted at the HepNet Study-House make up the largest trials in this field in the world so far. In addition, over the past few years, the HepNet Study-House has established an international network to include a patient database known as the Hepatitis Delta International Network (www.hepatitis-delta.org). Meanwhile, all leading scientists in the field of hepatitis D are involved in this network. Two meetings take place on an annual basis, and include approximately 100 participants each. Over 1,800 patients from all parts of the world have already been included in the patient database. The first data analysis was published in Liver International in 2017. As part of the approval of the first drug for the treatment of hepatitis D (Hepcludex®) in 2020, another European hepatitis delta registry was launched with the participation of the Study-House.
In addition to the two central themes - acute hepatitis C and hepatitis D - the world's first study on the treatment of chronic hepatitis E (HepNet pilot trial: Multicenter trial for the treatment of chronic hepatitis E with sofosbuvir (SofE)) was conducted at the HepNet Study-House. The results were published in the Journal of Hepatology in 2020. Samples obtained from this trial will be used by various working groups in the hepatitis research field and the initial results will be presented at various congresses.
The establishment of a national hepatitis E registry is planned for 2021.
In 2021, an existing hepatitis B patient cohort will also be expanded in a European network. The collection of comprehensive data in registries is an important tool for improving treatment options and characterising patient populations. In addition to its own scientific questions, one goal of the European HBV Registry is to support the recruitment of DZIF clinical research projects in a precisely characterised patient population.
Summary
With its clinical trials and patient cohorts, the HepNet Study-House continues to make significant contributions towards the development of new therapeutic approaches and the optimisation of existing therapies.
Successful cooperation between university medicine, research and the pharmaceutical industry enable large multicentre IIT trials (investigator initiated trials) to be conducted and support translational research in the field of viral hepatitis.
