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

Primary Purpose

Chronic Hepatitis B and Hepatitis D Co-infection

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HH-003 20mg/kg
HH-003 3mg/kg
Sponsored by
Huahui Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B and Hepatitis D Co-infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HH-003 20mg/kg

HH-003 3mg/kg

Arm Description

HH-003 20mg/kg, intravenously, Q2W

HH-003 3mg/kg, intravenously, Q2W

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of participants with ALT normalization at week 24
Changes from Baseline in Serum HBsAg Levels during the Study Period
Changes from Baseline in Serum HBV RNA Levels during the Study Period
Changes from Baseline in Serum HBV DNA Levels during the Study Period
Changes from Baseline in Serum HDV RNA Levels during the Study Period
Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening

Full Information

First Posted
December 30, 2022
Last Updated
October 6, 2023
Sponsor
Huahui Health
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1. Study Identification

Unique Protocol Identification Number
NCT05674448
Brief Title
A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollment in advance after discussion with the lead investigator.
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huahui Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B and Hepatitis D Co-infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HH-003 20mg/kg
Arm Type
Experimental
Arm Description
HH-003 20mg/kg, intravenously, Q2W
Arm Title
HH-003 3mg/kg
Arm Type
Experimental
Arm Description
HH-003 3mg/kg, intravenously, Q2W
Intervention Type
Biological
Intervention Name(s)
HH-003 20mg/kg
Intervention Description
HH-003 20mg/kg Q2W intravenously for 24 weeks
Intervention Type
Biological
Intervention Name(s)
HH-003 3mg/kg
Intervention Description
HH-003 3mg/kg Q2W intravenously for 24 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Time Frame
Week 24
Title
Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Time Frame
Week 24
Title
Change from Baseline in Serum HBsAg Levels at Week 24
Time Frame
from baseline to Week 24
Secondary Outcome Measure Information:
Title
Percentage of participants with ALT normalization at week 24
Time Frame
Week 24
Title
Changes from Baseline in Serum HBsAg Levels during the Study Period
Time Frame
from baseline to Week 48
Title
Changes from Baseline in Serum HBV RNA Levels during the Study Period
Time Frame
from baseline to Week 48
Title
Changes from Baseline in Serum HBV DNA Levels during the Study Period
Time Frame
from baseline to Week 48
Title
Changes from Baseline in Serum HDV RNA Levels during the Study Period
Time Frame
from baseline to Week 48
Title
Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening
Time Frame
from baseline to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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