Treatment for inactive chronic hepatitis B patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Peginterferon Alfa-2B in patients with inactive chronic hepatitis B (CHB) to assess its effectiveness in achieving a functional cure. The study focuses on individuals aged 18-60 who have been HBsAg positive for over six months and meet specific criteria regarding their HBV DNA levels and liver enzyme levels. The trial aims to address the lack of consensus in current guidelines regarding antiviral therapy for this patient population. Participants will be monitored for their response to treatment and any potential side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-60, no gender limitation
* HBsAg is positive for more than 6 months
* Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive
* Serum HBV DNA is less than 2000 IU/mL
* Alanine aminotransferase(ALT) and/or Aspartate aminotransferase(AST) is normal
* No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment
* Good compliance and voluntarily signed informed consent

Exclusion Criteria:

* Allergic to pegylated interferon α-2b
* Any indication of liver cirrhosis
* Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV)
* Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.)
* There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus
* Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism)
* Confirmed or suspected liver cancer or other malignant tumors
* Patients after or preparing for organ transplantation
* Peripheral blood white blood cell count \< 3.5×109/L and/or platelet count \< 80×109/L
* Under immunosuppressant treatment
* Pregnant or planned pregnancy in a short term or lactation patients
* Alcohol abuse (average alcohol intake is more than 40 g/d in males or 20g/d in women) or drug addicts
* Present or past history of mental or psychological diseases
* Other conditions that the investigators deem inappropriate for the study.

Where it's running

• Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Guizhou Zou — The Second Hospital of Anhui Medical University
• Study coordinator: Zhishuo Mo, Master
• Email: vbstone@126.com
• Phone: +86 13632434363

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.