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

• Sponsor: Huahui Health (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05839639
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: NrtIs; Drug: HH-003; Drug: HH-003+NrtIs	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Controlled Phase IIa 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
• Actual Study Start Date: Oct 9, 2021
• Actual Primary Completion Date: Dec 5, 2022
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NrtIs	Drug: NrtIs; Subjects will receive NrtIs therapy for 24 weeks.
Experimental: HH-003	Drug: HH-003; Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks.
Experimental: HH-003+NrtIs	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.

Outcome Measures

Primary Outcome Measures

1. Proportion of participants achieving sustained viral response [From baseline to Week 24]

2. Changes from baseline in serum HBsAg levels [From treatment start to Week 24]

Secondary Outcome Measures

1. Proportion of participants with undetectable HBV DNA in those with positive HBV DNA at baseline [From treatment start to Week 24]

2. Proportion of participants achieving sustained viral response [From baseline to Week 48]

3. Duration of sustained viral response [From treatment start to Week 48]

4. Changes from baseline in serum HBsAg levels [From treatment start up to Week 48]

5. Proportion of participants with HBV pgRNA negativation in those with positive HBV pgRNA at baseline [From baseline to Week 24]

6. Proportion of participants with normal ALT levels [From treatment start to Week 48]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

• Huahui Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huahui Health
• ClinicalTrials.gov Identifier: NCT05839639
• Other Study ID Numbers: HH003-202
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

No Results Posted as of May 3, 2023