This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Subcutaneous injection
Stanford University
Palo Alto, California, United States
NOT_YET_RECRUITINGUniversity of Maryland
Baltimore, Maryland, United States
NOT_YET_RECRUITINGNYU Langone Health
New York, New York, United States
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ)
Time frame: 24 Weeks post AHB-137 treatment (Week 48)
Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ
Time frame: Off-treatment follow-up (Week 48 to 72)
Proportion of participants with HBsAg < LOD
Time frame: Week 72
Proportion of participants with HBV DNA < LLOQ
Time frame: From baseline through Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA post AHB-137 treatment
Time frame: 24 weeks post AHB-137 treatment
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA at weeks 48 and 72
Time frame: 24 weeks post AHB-137 treatment and at Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA
Time frame: From baseline through end of study (Week 72)
Proportion of participants with HBsAg < or ≥ LOD (0.05 IU/mL) and/or HBV DNA < or ≥ LLOQ
Time frame: From baseline through end of study (Week 72)
Proportion of participants with highly sensitive HBsAg < LOD (0.005 IU/mL)
Time frame: From baseline through end of study (Week 72)
Proportion of participants with protocol-defined levels of HBsAg
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Texas Liver Institute
San Antonio, Texas, United States
RECRUITINGUniversity of Calgary
Calgary, Alberta, Canada
NOT_YET_RECRUITINGToronto General Hospital
Toronto, Ontario, Canada
NOT_YET_RECRUITINGHôpital Beaujon
Clichy, France
NOT_YET_RECRUITINGClinica Mangiagalli
Milan, Milan, Italy
NOT_YET_RECRUITINGVall d'Hebron Hospital
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGKing's College Hospital
London, London, United Kingdom
NOT_YET_RECRUITINGTime frame: From baseline through end of study (Week 72)
Proportion of participants that meet nucleos(t)ide analog (NA) discontinuation criteria
Time frame: Week 48
Categorical change from baseline in HBsAg levels, defined as reductions of ≥0.5, ≥1.0, ≥1.5, ≥2.0, or ≥3.0 log₁₀ IU/mL, assessed at each scheduled study visit
Time frame: From baseline through end of study (Week 72)
Proportion of participants with anti-HBs seroconversion (with hepatitis B surface antibody [HBsAb] > 10 IU/L)
Time frame: Weeks 24, 48, and 72
Quantitative hepatitis B virologic and serologic markers over time
Actual values and change from baseline over time in available quantitative hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B virus (HBV) DNA, HBV ribonucleic acid (RNA), hepatitis B core-related antigen (HBcrAg), hepatitis B e antibody (HBeAb), and qualitative and/or quantitative hepatitis B e antigen (HBeAg), summarized descriptively.
Time frame: From baseline through end of study (Week 72)
Proportion of participants who experience virologic relapse
Time frame: From baseline through Week 72
Time from nucleos(t)ide analog (NA) therapy discontinuation to virologic relapse
Time frame: From NA therapy discontinuation (Week 48) through end of follow-up (Week 72)
Change from baseline in alanine aminotransferase (ALT)
Time frame: From baseline through end of study (Week 72)
Proportion of participants with baseline ALT above the upper limit of normal (ULN) who achieve ALT normalization
Time frame: From baseline through end of study (Week 72)
Proportion of patients with drug-resistant mutations
Time frame: From baseline through end of study (Week 72)
Proportion of participants with treatment-emergent adverse events (TEAEs)
Proportion of participants who experience treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study treatment.
Time frame: From first dose (Day 1) through end of study (Week 72)
Proportion of participants with detectable anti-drug antibody (ADA) to AHB-137 and corresponding ADA titers
Time frame: From baseline through end of study (Week 72)
Area under the plasma concentration-time curve (AUC) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Concentration at the end of the dosing interval (Ct) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Maximum observed plasma concentration (Cmax) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Time to maximum observed plasma concentration (Tmax) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Apparent plasma clearance (CL/F) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Area Under the Plasma Concentration-Time Curve (AUC) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)
Plasma Concentration of AHB-137 at the End of the Dosing Interval (Cτ)
Time frame: From first dose (Day 1) through end of study (Week 72)
Maximum Observed Plasma Concentration (Cmax) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)
Time to Maximum Observed Plasma Concentration (Tmax) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)
Apparent Plasma Clearance (CL/F) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)