A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection

NCT05861674 | Completed Phase 2 FDA Drug

• 1 other identifier: HH003-204
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis Delta Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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 24 of the treatment period

Secondary Outcomes (12)

• 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 treatment period

• Proportion of subjects with ALT normalization

  At Week 24 of the treatment period

• Change from baseline in liver stiffness measurement (LSM)

  At Week 24 of the treatment 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

• 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 48 of the treatment period

Study Arms (3)

HH-003 (20mg/kg)+TAF

EXPERIMENTAL

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.

Biological: HH-003(20mg/kg); Drug: TAF

HH-003 (10mg/kg)+TAF

EXPERIMENTAL

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.

Biological: HH-003(10mg/kg); Drug: TAF

TAF

OTHER

Subjects will receive TAF 25 mg QD orally during 48-week treatment period and 24-week follow-up period.

Drug: TAF

Interventions

HH-003(20mg/kg) BIOLOGICAL

20 mg/kg Q2W intravenously for 48 weeks

HH-003 (20mg/kg)+TAF

HH-003(10mg/kg) BIOLOGICAL

10 mg/kg Q2W intravenously for 48 weeks

HH-003 (10mg/kg)+TAF

TAF DRUG

TAF 25 mg QD orally during 48-week treatment period and 24-week follow-up period

HH-003 (10mg/kg)+TAF; HH-003 (20mg/kg)+TAF; TAF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ×ULN\<Alanine aminotransferase (ALT) \<10×ULN at screening;

You may not qualify if:

• 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;
• Absolute neutrophils\<1,500/mm3 (1.5×109/L);
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 (according to the calculation equation of CKD-MDRD);
• Concomitant decompensated cirrhosis (cirrhosis with complications of portal hypertension and/or decreased hepatic function). The diagnosis of cirrhosis is based on, but not limited to: liver imaging assessment within 6 months prior to randomization (including screening period) (e.g.: liver ultrasound) or cirrhosis indicated by histopathology of liver biopsy, or liver stiffness measurement LSM≥17 kPa at screening, refer to more serious reported findings;
• Hepatic insufficiency within 3 months prior to randomization (including but not limited to: ascites, hepatic encephalopathy, upper gastrointestinal hemorrhage);
• Previous or current hepatocellular carcinoma (HCC) or suspicion for HCC suggested by liver histopathology or liver imaging; or serum alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening;

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (1)

Beijing Ditan Hospital Captial Medical University

Beijing, Beijing Municipality, 100015, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 17, 2023
• Study Start: June 16, 2023
• Primary Completion: July 18, 2024
• Study Completion: June 21, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)