Hepatitis B, Chronic study: Pegylated Interferon-alpha
Official title Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens
ClinicalTrials.gov ID: NCT06923280
What this study is testing
What is Pegylated Interferon-alpha (IFN)?
An investigational once‑weekly injectable medicine being studied as a potential treatment for chronic hepatitis B. It is designed to enhance the immune system’s ability to fight hepatitis B virus by stimulating antiviral immune responses.
Also referred to as peginterferon alfa-2a.
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
- The study will see if starting pegylated interferon alfa right away or after a waiting period improves loss of hepatitis B surface antigen, and whether intermittent dosing is as safe and effective as continuous dosing.
- Who it's for
- Adults with chronic hepatitis B who have completed ASO/siRNA treatment and still have detectable hepatitis B surface antigen.
- What's involved
- Participants will receive pegylated interferon alfa injections for 24 weeks either immediately or after a 24‑week observation period, with blood tests to check virus levels, liver function, and safety every 12 weeks.
- Time commitment
- The trial runs up to 96 weeks, requiring clinic visits and blood draws roughly every 12 weeks.
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 80
You may be able to join if
- Age ≥18 years.
- Chronic HBV infection (documented HBsAg positivity for \>6 months).
- Received ≥1 dose of ASO/siRNA (or matched placebo, if applicable).
- Achieved ≥1 log10 IU/mL HBsAg decline from baseline during prior therapy.
- Discontinued ASO/siRNA therapy before screening.
You likely can't join if
- Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before/during screening).
- Elevated AFP: Screening AFP \>100 ng/mL; AFP 20-100 ng/mL with imaging-confirmed hepatocellular carcinoma (ultrasound/CT/MRI).
- Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus...
- Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for \>2 weeks within 6 months before enrollment.
- Pregnancy, lactation, or plans for pregnancy during the study.
- Autoimmune hepatitis.
See the full eligibility criteria
- Age ≥18 years.
- Chronic HBV infection (documented HBsAg positivity for \>6 months).
- Received ≥1 dose of ASO/siRNA (or matched placebo, if applicable).
- Achieved ≥1 log10 IU/mL HBsAg decline from baseline during prior therapy.
- Discontinued ASO/siRNA therapy before screening.
- Screening HBsAg: 1-500 IU/mL.
- No prior interferon (IFN) therapy within 6 months before enrollment.
- Willingness to comply with study-related treatments, tests, and procedures.
- Commitment to contraception during the study.
- Voluntary participation with signed informed consent.
- Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before/during screening).
- Elevated AFP: Screening AFP \>100 ng/mL; AFP 20-100 ng/mL with imaging-confirmed hepatocellular carcinoma (ultrasound/CT/MRI).
- Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV).
- Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for \>2 weeks within 6 months before enrollment.
- Pregnancy, lactation, or plans for pregnancy during the study.
- Autoimmune hepatitis.
- Active autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus).
- Uncontrolled cardiovascular disease (e.g., unstable angina, myocardial infarction within 6 months).
- Poorly controlled endocrine disorders (e.g., diabetes mellitus, thyroid dysfunction).
- Severe psychiatric disorders: History of depression, anxiety, bipolar disorder, schizophrenia, or family history of psychiatric conditions (especially depression).
- Substance abuse: Alcohol (\>40 g/day for males; \>20 g/day for females) or Illicit drug use.
- Severe retinopathy or ophthalmologic disorders.
- Renal diseases: Chronic nephritis, renal insufficiency, nephrotic syndrome.
- Major organ dysfunction (e.g., heart, lung, pancreas).
- Organ transplant recipients or candidates.
- Hypersensitivity to interferon or excipients.
- Concurrent participation in other HBV-related treatment trials.
- Other conditions deemed unsuitable by investigators (e.g., non-compliance risk).
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, China, China
- Shanghai, China, China
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, China, China; Shanghai, China, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.