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.