The Clinical Cure Project of Chronic Hepatitis B in China

Study Overview
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Brief Summary
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Chronic hepatitis B is a global public health problem, with nearly 700,000 deaths each year because of hepatitis B-related diseases. Recent studies have found that some patients who have used nucleot(s)ide analogues(NAs) for some period can achieve higher hepatitis B surface antigen(HBsAg) clearance rate(which is called clinical cure or functional cure) by using pegylated interferon. Patients who achieve clinical cure will further reduce liver inflammation, fibrosis and risks of liver cirrhosis and cancer in the future. This study was initiated in May 2018 and plans to recruit 30,000 eligible patients. The enrollment conditions are as follows: 1. according with the diagnosis of chronic hepatitis B in the guideline of China in 2015; 2.18-60 years old; 3. more than 1 year history of NAs therapy with HBsAg ≤1500 IU/ml, negative hepatitis e antigen and hepatitis B virus DNA<100 IU/ml; 4. no contraindications of interferon. For the above patients, pegylated interferon was used for 1-2 years(combined with NAs for at least 3 months).The primary goal of this study is to find out the optimal treatment for clinical cure.

Official Title
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A Study of Peg-interferon Treatment for Nucleos(t)Ide Analogues Suppressed Chronic Hepatitis B Patients With Low Level Hepatitis Surface Antigen

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: pegylated interferon-alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: according with the diagnosis of chronic hepatitis B in the guideline of China in 2015 18-60 years old more than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA<100 IU/ml no contraindications of interferon Exclusion Criteria: Allergy to interferon Alanine transaminase >10 times of upper limit of normal(ULN) or total bilirubin >2 times of ULN existing or previous decompensated liver cirrhosis White blood cells or Platelet below the lower limit of normal existing severe organ injury combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism confirmed or suspected malignant tumors before or after transplantation using immunosuppressor pregnant or having a planned parenthood in 2 years alcohol or drug addicted infected by HIV any conditions that is unsuitable to interferon therapy according to the doctors' judgement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: short-course combination group<br>Nucleoside analogue is used during the first 3 months. | Drug: pegylated interferon-alfa<br>* All the patients in this study will receive pegylated interferon for all course.<br>|
| Experimental: full-course combination group<br>Nucleoside analogue is used during all the course of study. | Drug: pegylated interferon-alfa<br>* All the patients in this study will receive pegylated interferon for all course.<br>|
| Experimental: Monotherapy group<br>Only Peg-IFN is used during all the course of study. | Drug: pegylated interferon-alfa<br>* All the patients in this study will receive pegylated interferon for all course.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatitis B surface antigen | hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml. | up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatitis B surface antibody | hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml. | up to 48 weeks |