Actively Recruiting
Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-05-01
5000
Participants Needed
1
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients. In recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB. The purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.
CONDITIONS
Official Title
Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years, any gender
- Positive hepatitis B surface antigen (HBsAg) for more than 6 months
- Negative hepatitis B e antigen (HBeAg) and positive anti-HBe antibody
- Serum HBV DNA less than 2000 IU/mL
- Normal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels
- No previous antiviral treatment including nucleoside analogs or interferon
- Good compliance and signed informed consent voluntarily
You will not qualify if you...
- Allergy to pegylated interferon alpha-2b
- Any signs of liver cirrhosis
- Coinfection with hepatitis A, C, D, E viruses or HIV
- Other liver diseases including drug-related, alcoholic, autoimmune, or genetic metabolic liver diseases
- Serious lesions in heart, lung, kidney, brain, or eye fundus
- Autoimmune diseases, unstable diabetes, or thyroid disorders
- Confirmed or suspected liver cancer or other malignancies
- History of or preparing for organ transplantation
- Low white blood cell count (<3.5x10^9/L) and/or low platelet count (<80x10^9/L)
- Current immunosuppressant treatment
- Pregnant, planning pregnancy soon, or breastfeeding
- Alcohol abuse (more than 40 g/day for males or 20 g/day for females) or drug addiction
- History of mental or psychological disorders
- Any other conditions deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
Research Team
Z
Zhishuo Mo, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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