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

NCT05674448 | Terminated Phase 2

• 1 other identifier: HH003-201
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis B and Hepatitis D Co-infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

HH-003 20mg/kg

EXPERIMENTAL

HH-003 20mg/kg, intravenously, Q2W

Biological: HH-003 20mg/kg

HH-003 3mg/kg

EXPERIMENTAL

HH-003 3mg/kg, intravenously, Q2W

Biological: HH-003 3mg/kg

Interventions

HH-003 20mg/kg BIOLOGICAL

HH-003 20mg/kg Q2W intravenously for 24 weeks

HH-003 20mg/kg

HH-003 3mg/kg BIOLOGICAL

HH-003 3mg/kg Q2W intravenously for 24 weeks

HH-003 3mg/kg

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 informed consent form;
• Male or female subjects aged from 18 to 70 years inclusively;
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: August 11, 2021
• Primary Completion: July 25, 2022
• Study Completion: January 4, 2023
• Last Updated: October 10, 2023

Record last verified: 2022-12

Locations

CN (1)