Clinical trial NCT05734807: A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia
Official title: A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 in Nucleos(t)Ide Analogues-treated Chronic Hepatitis B Subjects With Low-Level Viremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic HBV Infection
Lead sponsor: Huahui Health
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form;
* Male or female aged from 18 to 60 years (inclusively);
* 18 kg/m\^2≤BMI≤30 kg/m\^2, body weight≥50 kg for men and ≥45 kg for women;
* Subjects who have chronic HBV infection greater than or equal to 6 months at screening;
* 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤2000 IU/mL; ALT≤3×ULN;
* Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening.

Exclusion Criteria:

* Females who are pregnant or lactating at screening;
* History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
* History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ;
* History or evidence of hepatocellular carcinoma at any time prior to or at time of screening;
* Exclusionary laboratory results at screening: total bilirubin \>2xULN or direct bilirubin \>1.5xULN，hemoglobin \<120 g/L for males or \<110 g/L ro females，platelets count\<100,000/mm\^3 (100×10\^9/L), and absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/L).

Primary outcomes:
measure: Percentage of subjects with HBV DNA negativation
timeFrame: Week 24
measure: Changes from baseline in serum HBsAg
timeFrame: From treatment start up to Week 48
Secondary outcomes:
measure: Percentage of subjects achieving maintained virologic response (MVR)
timeFrame: From treatment start up to 48 weeks
measure: Duration of MVR
timeFrame: From treatment start up to 48 weeks
measure: Percentage of subjects with ALT normalization
timeFrame: From treatment start up to 48 weeks
measure: Changes from baseline in serum HBeAg in subjects with positive HBeAg
timeFrame: From treatment start up to 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital,Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: The Sixth Peoples Hospital Of Zhengzhou
state: Henan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
Study officials:
References: