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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05734807
Other study ID # HH003-203
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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).

Study Design


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
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