Hepatitis B is a serious viral infection that can lead to chronic liver inflammation, cirrhosis, and liver cancer.

Globally, around 300 million people live with chronic hepatitis B, and existing treatments can slow the disease but cannot cure it.

With the new trial, researchers hope to take an important step toward developing a cure for hepatitis B.

Monoclonal antibodies as a new treatment

Researchers from Aarhus University and Aarhus University Hospital (AUH) and Charité have entered into an agreement with Rockefeller University, which discovered the monoclonal antibody, to test it in a phase 1 clinical trial on patients in Denmark and Germany.

In animal studies, the monoclonal antibody has been shown to bind to and eliminate the hepatitis B virus in the blood. The antibody has never before been tested in higher doses in humans, and the trial is primarily aimed at assessing the safety of the treatment. At the same time, the researchers will investigate whether the antibody is effective against the hepatitis B virus.

"If the monoclonal antibody proves to be safe and effective, it could open up new treatment options that may eventually lead to a cure for chronic hepatitis B," says Professor and Chief Physician Ole Schmeltz Søgaard from the Department of Clinical Medicine. 

Trial structure and treatment process

In the trial, a small group of patients will receive increasing doses of the antibody to ensure that it is well tolerated. As safety is confirmed, the trial will be expanded to a larger patient group to gather more information about the optimal dose.

Patients will receive a single infusion and will be closely monitored with blood tests for up to 48 weeks. Participants receiving placebo will also have the opportunity to receive the antibody once the trial reaches its expanded phase.

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

The future of hepatitis B treatment

The trial is the first of its kind in the world and 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 potential for monoclonal antibodies to contribute to future treatment options.

"From other diseases like HIV and cancer, we know that monoclonal antibodies can enhance the immune system's ability to fight the disease on its own, and the hope is that the same can be true for hepatitis B," says Ole Schmeltz Søgaard.

Contact: 

Professor and Chief Physician Ole Schmeltz Søgaard
Aarhus University, Department of Clinical Medicine
Aarhus University Hospital, Infectious Diseases
Phone: +45 27215985
Mail: olesoega@rm.dk