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

NCT ID: NCT05734807

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2024-04-17

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.

Conditions

Chronic HBV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NrtIs

Group Type: ACTIVE_COMPARATOR

Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)

Intervention Type: DRUG

Subjects will receive NrtIs therapy for 24 weeks.

HH-003+NrtIs

Group Type: EXPERIMENTAL

HH-003 and NrtIs

Intervention Type: DRUG

Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.

HH-003+NrtIs+PEG-IFN-α

Group Type: EXPERIMENTAL

HH-003, NrtIs and PEG-IFN-α

Intervention Type: DRUG

Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.

Interventions

Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)

Subjects will receive NrtIs therapy for 24 weeks.

Intervention Type: DRUG

HH-003 and NrtIs

Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.

Intervention Type: DRUG

HH-003, NrtIs and PEG-IFN-α

Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huahui Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Mengchao Hepatobiliary Hospital Of Fujian Medical University

Fuzhou, Fujian, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Sixth Peoples Hospital Of Zhengzhou

Zhengzhou, Henan, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

Countries

China

Other Identifiers

HH003-203

Identifier Type: -

Identifier Source: org_study_id