search
Back to results

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

Primary Purpose

Chronic HBV Infection

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
HH-003 and NrtIs
HH-003, NrtIs and PEG-IFN-α
Sponsored by
Huahui Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic HBV Infection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Beijing Ditan Hospital,Capital Medical University
  • Beijing Friendship Hospital,Capital Medical University
  • Beijing Youan Hospital,Capital Medical University
  • Mengchao Hepatobiliary Hospital Of Fujian Medical University
  • Nanfang Hospital of Southern Medical University
  • The Sixth Peoples Hospital Of Zhengzhou
  • The First Hospital of Jilin University
  • Shandong Public Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

NrtIs

HH-003+NrtIs

HH-003+NrtIs+PEG-IFN-α

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects with HBV DNA negativation
Changes from baseline in serum HBsAg

Secondary Outcome Measures

Percentage of subjects achieving maintained virologic response (MVR)
Duration of MVR
Percentage of subjects with ALT normalization
Changes from baseline in serum HBeAg in subjects with positive HBeAg

Full Information

First Posted
February 9, 2023
Last Updated
September 25, 2023
Sponsor
Huahui Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05734807
Brief Title
A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
April 24, 2023 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HBV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NrtIs
Arm Type
Active Comparator
Arm Title
HH-003+NrtIs
Arm Type
Experimental
Arm Title
HH-003+NrtIs+PEG-IFN-α
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
Intervention Description
Subjects will receive NrtIs therapy for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
HH-003 and NrtIs
Intervention Description
Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
HH-003, NrtIs and PEG-IFN-α
Intervention Description
Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.
Primary Outcome Measure Information:
Title
Percentage of subjects with HBV DNA negativation
Time Frame
Week 24
Title
Changes from baseline in serum HBsAg
Time Frame
From treatment start up to Week 48
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving maintained virologic response (MVR)
Time Frame
From treatment start up to 48 weeks
Title
Duration of MVR
Time Frame
From treatment start up to 48 weeks
Title
Percentage of subjects with ALT normalization
Time Frame
From treatment start up to 48 weeks
Title
Changes from baseline in serum HBeAg in subjects with positive HBeAg
Time Frame
From treatment start up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Beijing Ditan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Youan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Mengchao Hepatobiliary Hospital Of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Sixth Peoples Hospital Of Zhengzhou
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450006
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130061
Country
China
Facility Name
Shandong Public Health Clinical Center
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250102
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs