Chronic HBV InfectionPhase 2NCT05734807

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

A Phase 2 study testing Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs), HH-003 and NrtIs and HH-003, NrtIs and PEG-IFN-α in people with Chronic HBV Infection, run by Huahui Health at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Chronic HBV Infection
What is being tested?: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs), HH-003 and NrtIs and HH-003, NrtIs and PEG-IFN-α
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 8 sitesChina
Study dates: 20 Jul 2022to 17 Apr 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100015
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069
The First Hospital of Jilin University
Changchun, Jilin, 130061
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, 350025
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Shandong Public Health Clinical Center
Jinan, Shandong, 250102
The Sixth Peoples Hospital Of Zhengzhou
Zhengzhou, Henan, 450006

Other trials in China

About this study

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

Conditions: Chronic HBV Infection
Being tested: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs), HH-003 and NrtIs, HH-003, NrtIs and PEG-IFN-α

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)Drug
Subjects will receive NrtIs therapy for 24 weeks.
HH-003 and NrtIsDrug
Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
HH-003, NrtIs and PEG-IFN-αDrug
Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.

Study groups in NCT05734807
Study group	Role	What they receive
NrtIs	Active comparator	Not described Receives: Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
HH-003+NrtIs	Experimental	Not described Receives: Drug: HH-003 and NrtIs
HH-003+NrtIs+PEG-IFN-α	Experimental	Not described Receives: Drug: HH-003, NrtIs and PEG-IFN-α

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202217 Apr 2024

First posted21 Feb 2023
Study start20 Jul 2022
Primary completion17 Apr 2024
Study completion17 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05734807
Sponsor's protocol ID: HH003-203
Status last verified: Oct 2024
First submitted: 9 Feb 2023
Last updated: 15 Oct 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic HBV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05734807
Acronym / sponsor ID: HH003-203
Conditions: Chronic HBV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Huahui HealthIndustry (pharma, biotech, devices)
Study start: 20 Jul 2022 (actual)
Primary completion: 17 Apr 2024 (actual)
Study completion: 17 Apr 2024 (actual)
First posted: 21 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
NrtIs	Active comparator	Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
HH-003+NrtIs	Experimental	Drug: HH-003 and NrtIs
HH-003+NrtIs+PEG-IFN-α	Experimental	Drug: HH-003, NrtIs and PEG-IFN-α

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)Subjects will receive NrtIs therapy for 24 weeks.	Drug	NrtIs
HH-003 and NrtIsSubjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.	Drug	HH-003+NrtIs
HH-003, NrtIs and PEG-IFN-αSubjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.	Drug	HH-003+NrtIs+PEG-IFN-α

Primary outcome

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

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.

Related trials for Chronic HBV Infection

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with HBV DNA negativation (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05734807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.