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

Sponsor

Huahui Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05734807

Collaborator

(none)

Enrollment

Locations

Arms

20.4

Anticipated Duration (Months)

9.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic HBV Infection	Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs) Drug: HH-003 and NrtIs Drug: HH-003, NrtIs and PEG-IFN-α	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 20, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NrtIs	Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs) Subjects will receive NrtIs therapy for 24 weeks.
Experimental: HH-003+NrtIs	Drug: HH-003 and NrtIs Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
Experimental: HH-003+NrtIs+PEG-IFN-α	Drug: HH-003, NrtIs and PEG-IFN-α Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.

Arm

Intervention/Treatment

Active Comparator: NrtIs

Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)

Subjects will receive NrtIs therapy for 24 weeks.

Experimental: HH-003+NrtIs

Drug: HH-003 and NrtIs

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

Experimental: HH-003+NrtIs+PEG-IFN-α

Drug: HH-003, NrtIs and PEG-IFN-α

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

Outcome Measures

Primary Outcome Measures

Percentage of subjects with HBV DNA negativation [Week 24]
Changes from baseline in serum HBsAg [From treatment start up to Week 48]

Secondary Outcome Measures

Percentage of subjects achieving maintained virologic response (MVR) [From treatment start up to 48 weeks]
Duration of MVR [From treatment start up to 48 weeks]
Percentage of subjects with ALT normalization [From treatment start up to 48 weeks]
Changes from baseline in serum HBeAg in subjects with positive HBeAg [From treatment start up to 48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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
(1.5×109/L).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing	China	100015
2	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing	China	100050
3	Beijing Youan Hospital,Capital Medical University	Beijing	Beijing	China	100069
4	Mengchao Hepatobiliary Hospital Of Fujian Medical University	Fuzhou	Fujian	China	350025
5	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510515
6	The Sixth Peoples Hospital Of Zhengzhou	Zhengzhou	Henan	China	450006
7	The First Hospital of Jilin University	Changchun	Jilin	China	130061
8	Shandong Public Health Clinical Center	Jinan	Shandong	China	250102

Sponsors and Collaborators

Huahui Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huahui Health

ClinicalTrials.gov Identifier:

NCT05734807

Other Study ID Numbers:

HH003-203

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis B

Hepatitis B, Chronic

Viremia

Reverse Transcriptase Inhibitors

Study Results

No Results Posted as of Feb 27, 2023