A Multicenter, Randomized, Controlled, Open-label Phase IIb Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Huahui Health
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization
Overview
Brief Summary
This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed the informed consent form;
- •Male or female aged 18 to 70 years;
- •Positive HBsAg at screening;
- •History of chronic HDV infection for at least 6 months prior to randomization. For subjects also recommended for anti-HBV therapy, previous first line NrtIs treatment (ETV, TDF, TAF) within at least 12 weeks prior to the planned start of study treatment or subject's willingness to take first line NrtIs treatment for at least 12 weeks prior to the planned start of study treatment is required;
- •Positive HDV antibody at screening;
- •HDV RNA ≥100 IU/mL at screening;
- •1×ULN\<Alanine aminotransferase (ALT) \<10×ULN at screening;
Exclusion Criteria
- •Subjects with known hypersensitivity to HH-003 and its components, history of severe allergic reaction to other therapeutic antibodies or severe allergic diseases;
- •Subjects with contraindications for TAF;
- •History of interferon therapy within 3 months before randomization;
- •Any of the following lab test results at screening:
- •Total bilirubin \>2×ULN (except for subjects with Gilbert syndrome);
- •Direct bilirubin \> 1.5×ULN ;
- •Platelets\<80,000/mm3 (80×109/L);
- •Serum Albumin \<35 g/L;
- •Prothrombin time international normalized ratio (INR) \>1.3;
- •Hemoglobin \<100 g/L;
Arms & Interventions
HH-003 (20mg/kg)+TAF
Subjects will receive HH-003 20 mg/kg Q2W intravenously and TAF 25 mg QD orally during 48-week treatment period, and receive TAF 25 mg QD orally during 24-week follow-up period.
Intervention: HH-003(20mg/kg) (Biological)
HH-003 (20mg/kg)+TAF
Subjects will receive HH-003 20 mg/kg Q2W intravenously and TAF 25 mg QD orally during 48-week treatment period, and receive TAF 25 mg QD orally during 24-week follow-up period.
Intervention: TAF (Drug)
HH-003 (10mg/kg)+TAF
Subjects will receive HH-003 10 mg/kg Q2W intravenously and TAF 25 mg QD orally during 48-week treatment period, and receive TAF 25 mg QD orally during 24-week follow-up period.
Intervention: HH-003(10mg/kg) (Biological)
HH-003 (10mg/kg)+TAF
Subjects will receive HH-003 10 mg/kg Q2W intravenously and TAF 25 mg QD orally during 48-week treatment period, and receive TAF 25 mg QD orally during 24-week follow-up period.
Intervention: TAF (Drug)
TAF
Subjects will receive TAF 25 mg QD orally during 48-week treatment period and 24-week follow-up period.
Intervention: TAF (Drug)
Outcomes
Primary Outcomes
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization
Time Frame: At Week 24 of the treatment period
Secondary Outcomes
- Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline(At Week 24 of the follow-up period)
- Proportion of subjects with ALT normalization(At Week 24 of the follow-up period)
- Change from baseline in liver stiffness measurement (LSM)(At Week 24 of the follow-up period)
- Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization(At Week 48 of the treatment period)
- Change from baseline in serum HDV RNA levels at different time points(Up to Week 72)
- Change from baseline in serum ALT levels at different time points(Up to Week 72)