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

Chronic HBV Infection Clinical Trial

Official title:

A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 in Nucleos(t)Ide Analogues-treated Chronic Hepatitis B Subjects With Low-Level Viremia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05734807
• Other study ID #: HH003-203
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 20, 2022
• Est. completion date: March 31, 2024

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: March 31, 2024
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Signed informed consent form;

• Male or female aged from 18 to 60 years (inclusively);

• 18 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;

• 10 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.

Exclusion Criteria:

• 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;

• Exclusionary laboratory 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).

Related Conditions & MeSH terms

• Chronic HBV Infection
• Hepatitis B
• Hepatitis B, Chronic
• Viremia

Intervention

Drug:
• Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
Subjects will receive NrtIs therapy for 24 weeks.
• HH-003 and NrtIs
Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
• HH-003, NrtIs and PEG-IFN-a
Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-a 180µg SC QW for 24 weeks.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing
China	Beijing Youan Hospital,Capital Medical University	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Mengchao Hepatobiliary Hospital Of Fujian Medical University	Fuzhou	Fujian
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Shandong Public Health Clinical Center	Jinan	Shandong
China	The Sixth Peoples Hospital Of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Huahui Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with HBV DNA negativation		Week 24
Primary	Changes from baseline in serum HBsAg		From treatment start up to Week 48
Secondary	Percentage of subjects achieving maintained virologic response (MVR)		From treatment start up to 48 weeks
Secondary	Duration of MVR		From treatment start up to 48 weeks
Secondary	Percentage of subjects with ALT normalization		From treatment start up to 48 weeks
Secondary	Changes from baseline in serum HBeAg in subjects with positive HBeAg		From treatment start up to 48 weeks