Study HH006-202 is designed to assesses the efficacy and safety of HH-006 in adults chronic HBV infection. Eligible participants will receive study treatment for 48 weeks. All treated patients will also undergo a follow-up period after last study drug treatment.
This is a multicenter, open-label Phase II clinical study, It aims to evaluate the efficacy, safety, and tolerability of HH-006 in untreated HBeAg-positive/negative chronic HBV infected individuals and those with HBeAg-negative chronic HBV infection who have been treated with NAs for more than one year. Study participants will undergo various screening examinations as per the protocol before enrollment. Eligible participants will be assigned to Cohort 1, Cohort 2, or Cohort 3 according to different inclusion and exclusion criteria (see Inclusion/Exclusion Criteria for details). Upon entering the study, participants in all cohorts will start a 4-week loading dose period of HH-006 480 mg QW, followed by HH-006 240 mg QW for 44 weeks. Participants in Cohort 3 will continue their pre-existing NAs therapy after enrollment. Evaluations will include changes in HBsAg/HBV DNA/ALT and safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
HH-006 480 mg SC injection every one week for 4 weeks and followed by 240 mg QW for 44 weeks
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGHBsAg change from baseline
value of HBsAg change from baseline
Time frame: week 24
HBsAg change from baseline
value of HBsAg change from baseline
Time frame: week 12, week 48 of treatment and week 24 of follow up
proportion of HBsAg loss
number of participants with HBsAg loss
Time frame: week 24, week 48 of treatment and week 24 of follow up
HBsAg change from baseline
value of HBsAg change from baseline
Time frame: up to 72 weeks
cohort 1and cohort 2: proportion of HBV DNA decreasing more than 1 log10/mL
number of participants with HBV DNA decreasing more than 1 log10/mL
Time frame: week 12, week 24, week 48 of treatment and week 24 of follow up
proportion of HBV DNA < LLOQ
number of participants with HBV DNA \< LLOQ
Time frame: week 12, week 24, week 48 of treatment and week 24 of follow up
HBV DNA change from baseline
value of HBV DNA change from baseline
Time frame: up to 72 weeks
proportion of ALT normalization
number of participants with ALT normalization
Time frame: week 12, week 24, week 48 of treatment and week 24 of follow up
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ALT change from baseline
value of ALT change from baseline
Time frame: up to 72 weeks
proportion of HBsAg seroconversion
number of participants with HBsAg seroconversion
Time frame: week 12, week 24, week 48 of treatment and week 24 of follow up
cohort1: proportion of HBeAg seroconversion
number of participants with HBeAg seroconversion
Time frame: week 12, week 24, week 48 of treatment and week 24 of follow up
cohort1: HBeAg change from baseline
value of HBeAg change from baseline
Time frame: up to 72 weeks
LSM change from baseline
value of LSM change from baseline
Time frame: week 24, week 48 of treatment and week 24 of follow up
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HH-006 in plasma
Time frame: up to 24 weeks follow-up
Maximum Plasma Concentration (Cmax)
Cmax of HH-006 in plasma
Time frame: up to 24 weeks follow-up
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HH-006 in plasma
Time frame: up to 24 weeks follow-up
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HH-006 in plasma
Time frame: up to 24 weeks follow-up
Apparent Plasma Clearance (CL/F)
CL/F of HH-006 in plasma
Time frame: up to 24 weeks follow-up
Apparent volume of distribution (Vd/F)
Vd/F of HH-006 in plasma
Time frame: up to 24 weeks follow-up
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: up to 72 weeks
Clinically significant abnormalities
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Time frame: up to 72 weeks follow-up
Titers of Anti-drug Antibody (ADA)
ADA analysis of HH-006
Time frame: up to 72 weeks