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New treatment option for Chronic Hepaititis B
Official title Immunomodulatory Therapy and Predictors of Clinical Cure in Chronic Hepatitis B
ClinicalTrials.gov ID: NCT07328711
What this study is testing
What is Hepatitis B Immunoglobulin (HBIg)?
Hepatitis B Immunoglobulin (HBIg) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for chronic hepaititis b.
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
- Achieving clinical cure, defined as hepatitis B surface antigen (HBsAg) seroclearance, represents a major research focus and an ideal therapeutic goal for chronic hepatitis B (CHB). A significant challenge in CHB management lies in promoting clinical cure, reducing relapse, and progressing towards complete cure.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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 60
You may be able to join if
- Aged 18 to 60 years (inclusive).
- Documented HBsAg and/or HBV DNA positivity for over 6 months.
- Achieved HBsAg seroclearance (\<0.05 IU/mL) following a PegIFNα-based treatment regimen.
- HBeAg negative and HBV DNA \<10 IU/mL.
- Good compliance and willingness to voluntarily sign the informed consent form.
You likely can't join if
- Current decompensated cirrhosis or a history of decompensated cirrhosis.
- Individuals with spontaneous or Nucleos(t)ide analogue-induced HBsAg seroclearance.
- Coinfection with other viruses, such as hepatitis A, C, D, E viruses, or human immunodeficiency virus (HIV).
- Severe concurrent physical or mental illnesses other than hepatitis B, including uncontrolled primary renal, cardiac, pulmonary, vascular...
- Use of corticosteroids, immunosuppressants, or chemotherapeutic agents within the 6 months prior to enrollment or at present.
- Concurrent other liver diseases such as alcoholic liver disease or autoimmune liver disease.
See the full eligibility criteria
- Aged 18 to 60 years (inclusive).
- Documented HBsAg and/or HBV DNA positivity for over 6 months.
- Achieved HBsAg seroclearance (\<0.05 IU/mL) following a PegIFNα-based treatment regimen.
- HBeAg negative and HBV DNA \<10 IU/mL.
- Good compliance and willingness to voluntarily sign the informed consent form.
- Current decompensated cirrhosis or a history of decompensated cirrhosis.
- Individuals with spontaneous or Nucleos(t)ide analogue-induced HBsAg seroclearance.
- Coinfection with other viruses, such as hepatitis A, C, D, E viruses, or human immunodeficiency virus (HIV).
- Severe concurrent physical or mental illnesses other than hepatitis B, including uncontrolled primary renal, cardiac, pulmonary, vascular, neurological, digestive, or severe metabolic diseases (e.g., uncontrolled...
- Use of corticosteroids, immunosuppressants, or chemotherapeutic agents within the 6 months prior to enrollment or at present.
- Concurrent other liver diseases such as alcoholic liver disease or autoimmune liver disease.
- Body Mass Index (BMI) \> 28 kg/m².
- Any other condition considered by the investigator to potentially compromise patient compliance or otherwise make the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
A stipend or compensation may be offered.
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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing 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.