Hepatitis B surface antigen clearance in inactive hepatitis B surface antigen carriers treated with peginterferon alfa-2a.
Ming-Hui Li, Yao Xie, Lu Zhang...
https://pubmed.ncbi.nlm.nih.gov/27239256Actively Recruiting
Phase 4
Age: 18Years - 60Years
All Genders
ID05182463
Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-05-01
5000
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying treatments for inactive chronic hepatitis B (CHB), a condition affecting millions worldwide and particularly common in China from perinatal infection. The study aims to compare the effectiveness of different antiviral treatment plans, including peginterferon and nucleoside analogs, to find factors leading to a functional cure for inactive CHB patients. This real-world, multi-center prospective study addresses variations in current treatment guidelines and the increasing desire for therapy among patients. The study evaluates several antiviral regimens: one using oral nucleoside analogs (like Entecavir or Tenofovir) for 12-24 weeks followed by peginterferon alfa-2b, combination therapy of nucleoside analogs with peginterferon for up to 96 weeks, peginterferon alone for up to 96 weeks, or nucleoside analogs alone for up to 96 weeks. Each treatment group has a follow-up period of 144 weeks to monitor long-term outcomes. Participants will undergo regular monitoring throughout treatment and follow-up, including blood tests to measure hepatitis B surface antigen (HBsAg) clearance, serological conversion, and viral DNA levels over up to 96 weeks of treatment and 144 weeks of follow-up. Researchers will also track safety and adherence during the study. The total study duration for each participant, including follow-up, may extend beyond two years to evaluate sustained treatment responses.
CONDITIONS
Brief Title
Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years, any gender
- Positive hepatitis B surface antigen (HBsAg) for more than 6 months
- Hepatitis B e antigen (HBeAg) negative and anti-HBe positive
- Serum HBV DNA less than 2000 IU/mL
- Normal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels
- No prior antiviral drug use including nucleoside analogues or interferon
- Able to comply with study requirements and voluntarily consent to participate
You will not qualify if you...
- Allergy to pegylated interferon alpha-2b
- Signs of liver cirrhosis
- Coinfection with hepatitis A, C, D, E viruses or HIV
- Other liver diseases such as drug-related, alcoholic, autoimmune, or genetic metabolic liver diseases
- Serious damage to major organs including heart, lung, kidney, brain, or eyes
- Autoimmune diseases, unstable diabetes, or thyroid disorders
- Confirmed or suspected liver cancer or other malignancies
- History of or planned organ transplantation
- Low white blood cell count (<3.5 x 10^9/L) or platelet count (<80 x 10^9/L)
- Use of immunosuppressant treatments
- Pregnancy, planned pregnancy soon, or breastfeeding
- Alcohol abuse or drug addiction
- Past or present mental or psychological disorders
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - Up to 96 weeks
Participants receive peginterferon alfa-2b and/or nucleoside analogs according to their assigned group, with treatment lasting up to 96 weeks.
Visit schedule depends on treatment group and clinical care
Follow-up
Duration - Up to 144 weeks
Participants are monitored after treatment completion for up to 144 weeks to assess long-term outcomes.
Follow-up visits scheduled during this period
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
Loading map...
Research Team
Z
Zhishuo Mo, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
A potent hepatitis B surface antigen response in subjects with inactive hepatitis B surface antigen carrier treated with pegylated-interferon alpha.
Zhenhuan Cao, Yali Liu, Lina Ma...
https://pubmed.ncbi.nlm.nih.gov/28407271Efficacy and safety of peginterferon alpha monotherapy in Chinese inactive chronic hepatitis B virus carriers.
Fengping Wu, Rui Lu, Yixin Liu...
https://pubmed.ncbi.nlm.nih.gov/33896094A predictive scoring system for the seroclearance of HBsAg in HBeAg-seronegative chronic hepatitis B patients with genotype B or C infection.
Jessica Liu, Mei-Hsuan Lee, Richard Batrla-Utermann...
https://pubmed.ncbi.nlm.nih.gov/23246508Analysis of the Efficacy and Safety of PEGylated Interferon-α2b Treatment in Inactive Hepatitis B Surface Antigen Carriers.
Yan Huang, Min Qi, Chengjin Liao...
https://pubmed.ncbi.nlm.nih.gov/34350562Short-term Peginterferon-Induced High Functional Cure Rate in Inactive Chronic Hepatitis B Virus Carriers With Low Surface Antigen Levels.
Qing-Lei Zeng, Zu-Jiang Yu, Jia Shang...
https://pubmed.ncbi.nlm.nih.gov/32626791Recurrence risk factors for chronic hepatitis B virus-infected patients who achieve functional cure with pegylated interferon-α-2b-based therapy: a multicenter pilot study.
Li-Jun Chang, Chun-Qiu Hao, Gui-Rong Rao...
https://pubmed.ncbi.nlm.nih.gov/40390028