Chronic Hepatitis B Virus InfectionPhase 2NCT07519330
Clinical Study to Evaluate the Efficacy and Safety of HH-006 in Patients With Chronic Hepatitis B Virus Infection
A Phase 2 study testing HH-006 in people with Chronic Hepatitis B Virus Infection, run by Huahui Health at 1 site in China.
Trial summary
Study HH006-202 is designed to assesses the efficacy and safety of HH-006 in adults chronic HBV infection. Eligible participants will receive study treatment for 48 weeks. All treated patients will also undergo a follow-up period after last study drug treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Hepatitis B Virus Infection
- What is being tested?
- HH-006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2026to 22 Mar 2028
- Phase
- Phase 2
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sex: male or female; Age: 18 to 45 years old (inclusive);
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI): 18 kg/m² ≤ BMI ≤ 28 kg/m²;
- HBsAg and/or HBV DNA positivity for more than 6 months (including 6 months), or previous liver biopsy results indicating chronic hepatitis B, or negative for anti-HBc IgM;
- Virological and liver function indicators at screening:
- Cohort 1: HBeAg-positive, 2000 IU/mL ≤ HBsAg ≤ 100,000 IU/mL, HBV DNA > 105 IU/mL, 2 × upper limit of normal (ULN) ≤ ALT ≤ 8 × ULN; Cohort 2: HBeAg-negative, 100 IU/mL ≤ HBsAg ≤ 3000 IU/mL, 20 IU/mL < HBV DNA ≤ 2000 IU/mL, ALT ≤ 5 × ULN; Cohort 3: HBeAg-negative, 100 IU/mL ≤ HBsAg ≤ 3000 IU/mL, HBV DNA ≤ 100 IU/mL, ALT ≤ 2 × ULN;
- Previous antiviral treatment:
Show all 10Show fewer
- Cohort 1 and Cohort 2: No interferon antiviral treatment within the past 1 year, and no nucleos(t)ide analogue (NA) treatment within the 6 months prior to screening; Cohort 3: No interferon antiviral treatment within the past 1 year; received only nucleos(t)ide analogue monotherapy for at least one year;
- Fully understand the study content, procedures, and possible adverse reactions, and sign the written informed consent form (ICF);
- Able to communicate effectively with the investigator and complete the study in accordance with the study requirements;
- Male subjects who have not undergone sterilization and female subjects who have been postmenopausal for less than two years must agree to take adequate and effective contraceptive measure from screening until the last follow-up visit.
Who cannot join
- Co-infected with hepatitis C, syphilis, or human immunodeficiency virus (HIV);
- At screening: total bilirubin ≥ 3 × ULN and direct bilirubin (DBil) > 1 × ULN; hemoglobin < 100 g/L; platelet count < 100,000/mm³ (100 × 109/L); absolute neutrophil count < 1,500/mm³ (1.5 × 109/L); serum albumin < 35 g/L; prothrombin time international normalized ratio (INR) > 1.3; glycated hemoglobin (HbA1c) ≥ 7%; estimated glomerular filtration rate (eGFR) (MDRD formula) < 60 mL/min/1.73 m² (Appendix 2 MDRD calculation formula);
- Clinically significant electrocardiogram (ECG) abnormalities (e.g., QTcF > 450 ms in males, > 470 ms in females, severe arrhythmias such as torsade de pointes, paroxysmal ventricular tachycardia, symptomatic atrial fibrillation/flutter requiring emergency treatment, complete atrioventricular block); poorly controlled or refractory hypertension (e.g., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg after medication use, etc.);
- Concurrent clinically significant other liver diseases, including but not limited to: moderate or severe fatty liver, alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, drug-induced liver injury, etc.;
- History of progressive hepatic fibrosis or cirrhosis at any time prior to or during screening;
- Current or prior history of hepatic decompensation manifestations, including but not limited to: ascites, hepatic encephalopathy, esophageal and gastric variceal bleeding, hepatorenal syndrome, etc.;
Show all 21Show fewer
- Previous history of hepatocellular carcinoma, or at screening: serum alpha-fetoprotein (AFP) ≥ 50 ng/mL; or liver ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of possible hepatocellular carcinoma;
- Concurrent severe diseases or clinical conditions in other systems that, in the investigator's judgment, make the participant unsuitable for inclusion in this study:
- Circulatory system diseases: e.g., unstable angina, myocardial infarction, congestive heart failure, etc.;
- Respiratory system diseases: e.g., severe chronic obstructive pulmonary disease, etc.;
- Primary or secondary kidney diseases (e.g., chronic renal decompensation, renal diseases secondary to diabetes, hypertension, vascular diseases, etc.);
- Endocrine system diseases: e.g., poorly controlled diabetes or thyroid diseases, etc.;
- Autoimmune diseases: e.g., systemic lupus erythematosus, primary immune thrombocytopenia, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, autoimmune hemolytic anemia, severe psoriasis, etc.;
- Neuropsychiatric disorders: e.g., epilepsy, schizophrenia, depression, etc.;
- Malignant tumors;
- Lactating women or those with a positive pregnancy test;
- Persistent alcohol consumption (average daily intake > 40 g alcohol for males, > 20 g alcohol for females) or illicit drug abuse within 6 months prior to screening (including the screening period);
- Participation in any clinical trial of a drug (except for those who did not receive the investigational product) or medical device (except for non-invasive medical devices) within 3 months prior to screening;
- Major trauma or major surgery within the past three months;
- History of allergy to HH-003, HH-006, or polysorbate 80;
- In the investigator's judgment, unsuitability for participation in this study, or close relationship with the study site: e.g., immediate family members of the investigator, or affiliated personnel (e.g., site staff or students).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 400000
About this study
Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of Multiple Dosing of HH-006 in Patients With Chronic Hepatitis B Virus Infection
Study HH006-202 is designed to assesses the efficacy and safety of HH-006 in adults chronic HBV infection. Eligible participants will receive study treatment for 48 weeks. All treated patients will also undergo a follow-up period after last study drug treatment.
Read the detailed description
This is a multicenter, open-label Phase II clinical study, It aims to evaluate the efficacy, safety, and tolerability of HH-006 in untreated HBeAg-positive/negative chronic HBV infected individuals and those with HBeAg-negative chronic HBV infection who have been treated with NAs for more than one year.
Study participants will undergo various screening examinations as per the protocol before enrollment. Eligible participants will be assigned to Cohort 1, Cohort 2, or Cohort 3 according to different inclusion and exclusion criteria (see Inclusion/Exclusion Criteria for details). Upon entering the study, participants in all cohorts will start a 4-week loading dose period of HH-006 480 mg QW, followed by HH-006 240 mg QW for 44 weeks. Participants in Cohort 3 will continue their pre-existing NAs therapy after enrollment. Evaluations will include changes in HBsAg/HBV DNA/ALT and safety.
- Conditions
- Chronic Hepatitis B Virus Infection
- Being tested
- HH-006
- Keywords
- chronic hepatitis B virus infection
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-006Biological
HH-006 480 mg SC injection every one week for 4 weeks and followed by 240 mg QW for 44 weeks
| Study group | Role | What they receive |
|---|---|---|
| HH-006 Cohort 1 | Experimental | untreated HBeAg-positive chronic HBV infected participants will receive HH-006 Receives: Biological: HH-006 |
| HH-006 Cohort 2 | Experimental | untreated HBeAg-negative chronic HBV infected participants will receive HH-006 Receives: Biological: HH-006 |
| HH-006 Cohort 3 | Experimental | participants with HBeAg-negative chronic HBV infection who have been treated with NAs for more than one year will receive HH-006 Receives: Biological: HH-006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg change from baseline
value of HBsAg change from baseline
Measured: week 24
Secondary outcomes (21)
HBsAg change from baseline
value of HBsAg change from baseline
Measured: week 12, week 48 of treatment and week 24 of follow up
proportion of HBsAg loss
number of participants with HBsAg loss
Measured: week 24, week 48 of treatment and week 24 of follow up
HBsAg change from baseline
value of HBsAg change from baseline
Measured: up to 72 weeks
cohort 1and cohort 2: proportion of HBV DNA decreasing more than 1 log10/mL
number of participants with HBV DNA decreasing more than 1 log10/mL
Measured: week 12, week 24, week 48 of treatment and week 24 of follow up
proportion of HBV DNA < LLOQ
number of participants with HBV DNA < LLOQ
Measured: week 12, week 24, week 48 of treatment and week 24 of follow up
HBV DNA change from baseline
value of HBV DNA change from baseline
Measured: up to 72 weeks
proportion of ALT normalization
number of participants with ALT normalization
Measured: week 12, week 24, week 48 of treatment and week 24 of follow up
ALT change from baseline
value of ALT change from baseline
Measured: up to 72 weeks
proportion of HBsAg seroconversion
number of participants with HBsAg seroconversion
Measured: week 12, week 24, week 48 of treatment and week 24 of follow up
cohort1: proportion of HBeAg seroconversion
number of participants with HBeAg seroconversion
Measured: week 12, week 24, week 48 of treatment and week 24 of follow up
cohort1: HBeAg change from baseline
value of HBeAg change from baseline
Measured: up to 72 weeks
LSM change from baseline
value of LSM change from baseline
Measured: week 24, week 48 of treatment and week 24 of follow up
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HH-006 in plasma
Measured: up to 24 weeks follow-up
Maximum Plasma Concentration (Cmax)
Cmax of HH-006 in plasma
Measured: up to 24 weeks follow-up
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HH-006 in plasma
Measured: up to 24 weeks follow-up
Apparent Terminal Elimination Half-life (T1/2)
T1/2 of HH-006 in plasma
Measured: up to 24 weeks follow-up
Apparent Plasma Clearance (CL/F)
CL/F of HH-006 in plasma
Measured: up to 24 weeks follow-up
Apparent volume of distribution (Vd/F)
Vd/F of HH-006 in plasma
Measured: up to 24 weeks follow-up
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: up to 72 weeks
Clinically significant abnormalities
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Measured: up to 72 weeks follow-up
Titers of Anti-drug Antibody (ADA)
ADA analysis of HH-006
Measured: up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start14 May 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion22 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519330
- Sponsor's protocol ID
- HH006-202
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No