This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.
Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements).
HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
HBsAg ≥LLOQ.
HBV DNA ≥20,000 IU/mL.
Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
Positive for anti-HBs antibodies.
History or current evidence of cirrhosis.
Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
Parallel
ALG-000184
Drug300 mg tablet
TDF
Drug300 mg tablet
HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected)
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target detected or target not detected) at Week 48
HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected)
HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target not detected) at Week 48
Safety and Tolerability
Number of participants with Treatment Emergent Adverse Events (TEAEs), with abnormal 12-lead electrocardiogram readings and abnormal clinical laboratory results.
HBV DNA levels
Categorized by HBV DNA ≥ Lower Limit of Quantification \[LLOQ\], HBV DNA \<Lower Limit of Quantification \[LLOQ\] (target detected), and HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target not detected)
HBV DNA < lower limit of quantification [LLOQ] (target detected or target not detected) [HBeAg positive]
HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target detected or target not detected) at various time points during the first 48 weeks
HBV DNA < Lower Limit of Quantification [LLOQ] (target not detected) [HBeAg negative]
HBV DNA \< Lower Limit of Quantification \[LLOQ\] (target not detected) at various time points during the first 48 weeks
Change in levels of various HBV antigens at various time points from Baseline
Change from baseline in levels of various HBV antigens
Histologic, virologic, immunologic and/or PK-related endpoints
Change in intrahepatic viral markers (e.g., HBV nucleic acid and antigen levels), immune cell populations, and inflammation/fibrosis biomarkers
Click on the lead sponsor to view all of their trials.
