10.10.2024

Hepatitis B is a serious viral infection, which may lead to chronic infection of the liver, cirrhosis and liver cancer. Worldwide, around 300 million people live with chronic hepatitis B. Existing treatments may slow down the disease but do not cure it. With this new clinical trial, researchers hope to take an important new step to find a new type of treatment and potentially cure for chronic hepatitis B.

The trial is a collaboration with the university hospital Charité in Berlin.

Researchers at AUH and Charité have entered a collaboration with The Rockefeller University, who invented the monoclonal antibody, to initiate a clinical phase 1 study involving patients in Denmark and Germany.

Animal studies have shown that the monoclonal antibody binds to and eliminates hepatitis B virus in the blood. The antibody has never been tested in higher doses in humans and the primary aim of the trial is thus to evaluate the safety of the treatment. At the same time researchers will investigate if the antibody is effective against hepatitis B virus.  

- If the monoclonal antibody is safe and effective, this may lead to new treatments and eventually a cure for chronic hepatitis B, says Ole Schmeltz Søgaard, MD and professor.

A small group of patients will receive increasing doses of the antibody to ensure that it is well tolerated. When this proves safe, the trial will expand to include a larger patient sample to gain more knowledge of the optimal dose.

The patients will receive one infusion and be closely monitored by blood samples for up to 48 weeks. Trial participants receiving placebo will also be offered treatment with the antibody when the trial is expanded to involve a larger patient sample.

The first two participants have already received treatment at AUH, without any serious side effects.

This trial represents a significant step forward in the fight against hepatitis B.

Although there is still a long way to go, researchers are optimistic about the contribution monoclonal antibodies may have to the future treatment of hepatitis B.

- We know from other diseases like HIV and cancer, that monoclonal antibodies can strengthen the ability of the immune system to fight the disease; we hope we will see the same for hepatitis B, says Ole Schmeltz Søgaard.