This study is looking at Chronic Hepatitis D Infection, which is a liver disease caused by the hepatitis D virus. People with this condition have long-term inflammation of the liver that can lead to serious liver problems over time. The study will test two different medications given as injections under the skin. The first medication is BJT-778, which is the main treatment being tested in this study. The second medication is bulevirtide, which participants are already receiving before joining the study. The purpose of the study is to see how well switching from bulevirtide to treatment with BJT-778 works for chronic hepatitis D infection after 24 weeks.
Participants entering this study must already be taking bulevirtide for at least 6 months for their chronic hepatitis D infection. They will also need to be taking one of the following medications for hepatitis B and continue taking it throughout the study: TDF, TAF, or ETV. During the study, participants will switch from their current bulevirtide treatment to receiving BJT-778 injections under the skin. The study will measure how many participants have the hepatitis D virus become undetectable in their blood after switching to the new treatment.
The study will also look at safety by tracking any unwanted effects that occur during treatment, how many participants stop treatment because of unwanted effects, and changes in bile salts in the blood. Other measurements will include how many participants have their virus levels drop significantly or become undetectable at different time points, whether liver enzyme levels called ALT return to normal, and whether the virus remains undetectable after treatment ends. The treatment period can last up to 96 weeks, with additional follow-up visits after treatment is completed.
Austria 
Czechia 
France 
Germany 
Italy 
Romania 
Spain 