BJT-778-302
Research type
Research Study
Full title
A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
IRAS ID
1011291
Contact name
Jenny Stanton
Contact email
Sponsor organisation
Bluejay Therapeutics, Inc.
Research summary
Hepatitis delta virus (HDV) causes a serious liver disease called chronic hepatitis delta (CHD), which is the most severe form of viral hepatitis. HDV can only infect people who are already infected with Hepatitis B virus (HBV) because it needs HBV proteins to spread. HDV can either infect someone at the same time as HBV or later, in those already dealing with chronic HBV. CHD leads to more severe liver damage, like cirrhosis, liver cancer, and liver failure, compared to just having HBV.
Currently, there is a need for better treatments for CHD, ones that are more effective, easier to use, and with fewer side effects. One treatment option, called bulevirtide, is currently approved for CHD. Bulevirtide is a daily subcutaneous (SC) injection that helps control HDV by blocking its ability to enter liver cells. While it can be effective, its daily injection can be inconvenient for patients.
Bluejay Therapeutics is developing a new treatment called brelovitug (BJT-778), a monoclonal antibody that specifically targets HDV. The goal of brelovitug is to neutralize HDV and clear it from the body. A Phase 3 study, called AZURE-2, will compare the effectiveness of brelovitug to bulevirtide in treating patients with chronic hepatitis delta. This study aims to see if brelovitug could offer a better solution for managing CHD.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0063
Date of REC Opinion
2 Apr 2025
REC opinion
Further Information Favourable Opinion