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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839639
• Other study ID #: HH003-202
• Status: Completed
• Phase: Phase 2
• Start date: October 9, 2021
• Est. completion date: May 17, 2023

Study information

• Verified date: September 2023
• Source: Huahui Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 17, 2023
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Huahui Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving sustained viral response		From baseline to Week 24
Primary	Changes from baseline in serum HBsAg levels		From treatment start to Week 24
Secondary	Proportion of participants with undetectable HBV DNA in those with positive HBV DNA at baseline		From treatment start to Week 24
Secondary	Proportion of participants achieving sustained viral response		From baseline to Week 48
Secondary	Duration of sustained viral response		From treatment start to Week 48
Secondary	Changes from baseline in serum HBsAg levels		From treatment start up to Week 48
Secondary	Proportion of participants with HBV pgRNA negativation in those with positive HBV pgRNA at baseline		From baseline to Week 24
Secondary	Proportion of participants with normal ALT levels		From treatment start to Week 48