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

NCT05734807 | Completed Phase 2

• 1 other identifier: HH003-203
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with HBV DNA negativation

  Week 24

• Changes from baseline in serum HBsAg

  From treatment start up to Week 48

Secondary Outcomes (4)

• Percentage of subjects achieving maintained virologic response (MVR)

  From treatment start up to 48 weeks

• Duration of MVR

  From treatment start up to 48 weeks

• Percentage of subjects with ALT normalization

  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

Study Arms (3)

NrtIs

ACTIVE COMPARATOR

Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)

HH-003+NrtIs

EXPERIMENTAL

Drug: HH-003 and NrtIs

HH-003+NrtIs+PEG-IFN-α

EXPERIMENTAL

Drug: HH-003, NrtIs and PEG-IFN-α

Interventions

Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs) DRUG

Subjects will receive NrtIs therapy for 24 weeks.

NrtIs

HH-003 and NrtIs DRUG

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

HH-003+NrtIs

HH-003, NrtIs and PEG-IFN-α DRUG

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

HH-003+NrtIs+PEG-IFN-α

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form;
• Male or female aged from 18 to 60 years (inclusively);
• 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (8)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Mengchao Hepatobiliary Hospital Of Fujian Medical University

Fuzhou, Fujian, 350025, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The Sixth Peoples Hospital Of Zhengzhou

Zhengzhou, Henan, 450006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130061, China

Location

Shandong Public Health Clinical Center

Jinan, Shandong, 250102, China

Location

MeSH Terms

Interventions

Nucleosides

Intervention Hierarchy (Ancestors)

Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: July 20, 2022
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (8)