A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia

Phase 2

Completed

• Conditions: Chronic HBV Infection
• Interventions: Drug: HH-003 and NrtIs; Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs); Drug: HH-003, NrtIs and PEG-IFN-α

• Registration Number: NCT05734807
• Lead Sponsor: Huahui Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-20
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Primary Completion: 2024-04-17
• Study Completion: 2024-04-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HH-003+NrtIs	HH-003 and NrtIs	-
NrtIs	Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)	-
HH-003+NrtIs+PEG-IFN-α	HH-003, NrtIs and PEG-IFN-α	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with HBV DNA negativation	Week 24
Changes from baseline in serum HBsAg	From treatment start up to Week 48

Secondary Outcome Measures

Name	Time	Method
Duration of MVR	From treatment start up to 48 weeks
Percentage of subjects achieving maintained virologic response (MVR)	From treatment start up to 48 weeks
Changes from baseline in serum HBeAg in subjects with positive HBeAg	From treatment start up to 48 weeks
Percentage of subjects with ALT normalization	From treatment start up to 48 weeks

Trial Locations

Locations (8)

Shandong Public Health Clinical Center; 🇨🇳 Jinan, Shandong, China

Beijing Youan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Ditan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

The Sixth Peoples Hospital Of Zhengzhou; 🇨🇳 Zhengzhou, Henan, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Beijing Friendship Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Mengchao Hepatobiliary Hospital Of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China