A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection

An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection

This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. 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/HDV.

Study Overview

• Status: Terminated
• Conditions: Chronic Hepatitis B and Hepatitis D Co-infection
• Intervention / Treatment: Biological: HH-003 20mg/kg; Biological: HH-003 3mg/kg

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent form;
• Male or female subjects aged from 18 to 70 years inclusively;
• 18 kg/m2≤BMI≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women;
• Positive HBsAg, anti-HDV IgG antibody and HDV RNA at screening;
• Women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer).

Exclusion Criteria:

• Be pregnant or lactating at screening;
• Subjects with decompensated liver cirrhosis;
• Subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening;
• Average daily alcohol consumption >40g for men and >20g for women or drug abuse within 6 months prior to screening;
• Subjects with other serious diseases that is inappropriate for study participation per the Investigator's or the Sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment);
• History of hepatocellular carcinoma (HCC) or hepatocellular carcinoma suggested by liver histopathology or liver imaging;
• Interferon antiviral therapy within 1 year prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HH-003 20mg/kg; HH-003 20mg/kg, intravenously, Q2W	Biological: HH-003 20mg/kg; HH-003 20mg/kg Q2W intravenously for 24 weeks
Experimental: HH-003 3mg/kg; HH-003 3mg/kg, intravenously, Q2W	Biological: HH-003 3mg/kg; HH-003 3mg/kg Q2W intravenously for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24	Week 24
Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24	Week 24
Change from Baseline in Serum HBsAg Levels at Week 24	from baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with ALT normalization at week 24	Week 24
Changes from Baseline in Serum HBsAg Levels during the Study Period	from baseline to Week 48
Changes from Baseline in Serum HBV RNA Levels during the Study Period	from baseline to Week 48
Changes from Baseline in Serum HBV DNA Levels during the Study Period	from baseline to Week 48
Changes from Baseline in Serum HDV RNA Levels during the Study Period	from baseline to Week 48
Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening	from baseline to Week 48

Collaborators and Investigators

• Sponsor: Huahui Health

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Infections; Communicable Diseases; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis D; Hepatitis B, Chronic; Hepatitis, Chronic; Coinfection
• Other Study ID Numbers: HH003-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No