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

NCT05839639 | Completed Phase 2

• 1 other identifier: HH003-202
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Proportion of participants achieving sustained viral response

  From baseline to Week 24

• Changes from baseline in serum HBsAg levels

  From treatment start to Week 24

Secondary Outcomes (6)

• Proportion of participants with undetectable HBV DNA in those with positive HBV DNA at baseline

  From treatment start to Week 24

• Proportion of participants achieving sustained viral response

  From baseline to Week 48

• Duration of sustained viral response

  From treatment start to Week 48

• Changes from baseline in serum HBsAg levels

  From treatment start up to Week 48

• Proportion of participants with HBV pgRNA negativation in those with positive HBV pgRNA at baseline

  From baseline to Week 24

Study Arms (3)

NrtIs

ACTIVE COMPARATOR

Drug: NrtIs

HH-003

EXPERIMENTAL

Drug: HH-003

HH-003+NrtIs

EXPERIMENTAL

Drug: HH-003+NrtIs

Interventions

NrtIs DRUG

Subjects will receive NrtIs therapy for 24 weeks.

NrtIs

HH-003 DRUG

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

HH-003

HH-003+NrtIs DRUG

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

HH-003+NrtIs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form;
• Male or female aged from 18 to 65years (inclusively);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: April 20, 2023
• First Posted: May 3, 2023
• Study Start: October 9, 2021
• Primary Completion: December 5, 2022
• Study Completion: May 17, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)