Clinical trial
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
Name
HH003-203
Description
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.
Trial arms
Trial start
2022-07-20
Estimated PCD
2023-04-24
Trial end
2024-03-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
Subjects will receive NrtIs therapy for 24 weeks.
Arms:
NrtIs
HH-003 and NrtIs
Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
Arms:
HH-003+NrtIs
HH-003, NrtIs and PEG-IFN-α
Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.
Arms:
HH-003+NrtIs+PEG-IFN-α
Size
75
Primary endpoint
Percentage of subjects with HBV DNA negativation
Week 24
Changes from baseline in serum HBsAg
From treatment start up to Week 48
Eligibility criteria
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2023-09-28
1 organization
2 products
1 indication
Indication
Chronic Hepatitis B InfectionOrganization
Huahui HealthProduct
HH-003