If you're living with chronic hepatitis delta virus infection, you know it's a tough liver disease to treat. A recent study tested a new approach: an antibody injection called HH-003. The idea was to see if this treatment could help control the virus and calm down liver inflammation. The study involved 101 people across multiple medical centers. They were randomly assigned to receive one of two different doses of the HH-003 injection or a standard antiviral medication called TAF. The main goal was to see how many people achieved two things: first, having the hepatitis delta virus become undetectable in their blood or drop by a significant amount, and second, having their liver enzyme levels (ALT) return to normal. This combination is important because it shows the virus is being controlled and the liver is healing. The study was open-label, meaning everyone knew which treatment they were getting. It was completed in mid-2024. The findings from this phase of research will help determine if this antibody approach is effective and safe enough to move forward in development for people with this infection.
Could a new antibody treatment help people with a serious liver infection?
Plain Language Summary
What this means for you:
A new antibody was tested to see if it can control hepatitis delta virus and improve liver health. What this means for you:
A new antibody was tested to see if it can control hepatitis delta virus and improve liver health. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Chronic Hepatitis Delta Virus Infection
Intervention(s): HH-003(20mg/kg) (BIOLOGICAL), HH-003(10mg/kg) (BIOLOGICAL), TAF (DRUG)
This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection.
Primary Outcome(s): Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization
Enrollment: 101 (ACTUAL)
Lead Sponsor: Huahui Health
Start: 2023-06-16 | Primary Completion: 2024-07-18