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Tests treatment safety and results for Chronic Hepatitis B Virus Infection
Official title Clinical Study to Evaluate the Efficacy and Safety of HH-006 in Patients With Chronic Hepatitis B Virus Infection
ClinicalTrials.gov ID: NCT07519330
What this study is testing
What is HH-006?
HH-006 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic hepatitis b virus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- 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...
- 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...
- Previous antiviral treatment: Cohort 1 and Cohort 2: No interferon antiviral treatment within the past 1 year, and no nucleos(t)ide analogue (NA)...
You likely can't join if
- Co-infected with hepatitis C, syphilis, or human immunodeficiency virus (HIV);
- At screening: total bilirubin ≥ 3 × ULN and direct bilirubin (DBil) \> 1 × ULN; hemoglobin \ 1.3; glycated hemoglobin (HbA1c) ≥ 7%; estimated...
- Clinically significant electrocardiogram (ECG) abnormalities (e.g., QTcF \> 450 ms in males, \> 470 ms in females, severe arrhythmias such as torsade...
- Concurrent clinically significant other liver diseases, including but not limited to: moderate or severe fatty liver, alcoholic liver disease...
- 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...
See the full eligibility criteria
- 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...
- Previous antiviral treatment: 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...
- 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 people who have not undergone sterilization and female people who have been postmenopausal for less than two years must agree to take adequate and effective contraceptive measure from screening until the last...
- Co-infected with hepatitis C, syphilis, or human immunodeficiency virus (HIV);
- At screening: total bilirubin ≥ 3 × ULN and direct bilirubin (DBil) \> 1 × ULN; hemoglobin \ 1.3; glycated hemoglobin (HbA1c) ≥ 7%; estimated glomerular filtration rate (eGFR) (MDRD formula) \< 60 mL/min/1.73 m²...
- 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...
- 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...
- 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.;
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.