Phase IIb trial of HH-003 injection for chronic HDV infection completes enrollment of 101 patients

A multicenter, randomized, controlled, open-label Phase IIb study was conducted to assess the efficacy and safety of HH-003 injection in subjects with chronic hepatitis delta virus infection. HH-003 is a monoclonal antibody targeting Hepatitis B virus. The study interventions included HH-003 at doses of 20mg/kg and 10mg/kg, as well as TAF. The study enrolled 101 patients. The primary outcome measure was the proportion of subjects achieving a composite endpoint of serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline, along with ALT normalization. The study was sponsored by Huahui Health, started on June 16, 2023, and reached primary completion on July 18, 2024. The abstract states the study status is 'COMPLETED' and provides the enrollment figure and study dates but does not report any specific efficacy results, safety data, statistical analyses (such as p-values, hazard ratios, or confidence intervals), or comparative outcomes between the intervention arms. Therefore, no numerical results on the primary or secondary endpoints, safety signals, or patient demographics are available from the provided abstract text.

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.