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Completed

NCT Number: NCT05734807

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Ditan Hospital,Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)

Drug

Subjects will receive NrtIs therapy for 24 weeks.

HH-003 and NrtIs

Drug

Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.

HH-003, NrtIs and PEG-IFN-α

Drug

Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.

Primary outcomes

  1. Percentage of subjects with HBV DNA negativation

    Time frame: Week 24

  2. Changes from baseline in serum HBsAg

    Time frame: From treatment start up to Week 48

Secondary outcomes

  1. Percentage of subjects achieving maintained virologic response (MVR)

    Time frame: From treatment start up to 48 weeks

  2. Duration of MVR

    Time frame: From treatment start up to 48 weeks

  3. Percentage of subjects with ALT normalization

    Time frame: From treatment start up to 48 weeks

  4. Changes from baseline in serum HBeAg in subjects with positive HBeAg

    Time frame: From treatment start up to 48 weeks

Sponsors and collaborators

Lead sponsor

Huahui Health

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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