A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors

NCT ID: NCT05839639

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-09
• Study Completion Date: 2023-05-17

Brief Summary

This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.

Conditions

Chronic Hepatitis B

Study Design

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

Study Groups

NrtIs

Group Type: ACTIVE_COMPARATOR

NrtIs

Intervention Type: DRUG

Subjects will receive NrtIs therapy for 24 weeks.

HH-003

Group Type: EXPERIMENTAL

HH-003

Intervention Type: DRUG

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

HH-003+NrtIs

Group Type: EXPERIMENTAL

HH-003+NrtIs

Intervention Type: DRUG

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

Interventions

NrtIs

Subjects will receive NrtIs therapy for 24 weeks.

Intervention Type: DRUG

HH-003

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

Intervention Type: DRUG

HH-003+NrtIs

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form;
• Male or female aged from 18 to 65years (inclusively);
• 18 kg/m^2≤BMI≤32 kg/m^2, body weight≥45 kg for men and ≥40 kg for women;
• At screening, etiological, clinical, or pathological evidence indicates chronic hepatitis B virus infection for at least 6 months; and negative HBeAg for more than 6 months; 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤20 IU/mL; ALT≤1×ULN;
• Participants who have been on the treatment of nucleos(t)ide reverse transcriptase inhibitors (limited to entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide fumarate [TAF]) for at least 3 years (as judged by the investigator) at screening.

Exclusion Criteria

• Females who are pregnant or lactating at screening;
• History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
• History or presence of progressive liver fibrosis or cirrhosis, including but not limited to liver stiffness measurement [LSM] ≥ 9 kPa at screening, progressive liver fibrosis or cirrhosis (e.g., S ≥ 3 in GS score or METAVIR ≥ F3) by liver histopathology examination, according to the Consensus on the diagnosis and therapy of hepatic fibrosis [2019]; or the presence of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, or esophageal and gastric varices.
• History or presence of hepatocellular carcinoma, or alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening; or suspicion of hepatocellular carcinoma indicated by liver ultrasound, CT, or MRI.
• Use of antiviral therapy with interferon within 1 year prior to screening
• Any of the following lab test 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), Serum albumin < 35 g/L; international normalized ratio (INR) of prothrombin time > 1.3; or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huahui Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

HH003-202

Identifier Type: -

Identifier Source: org_study_id