Hepatitis B, Chronic
Conditions
Brief summary
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.
Interventions
DRUGpegylated interferon-alfa
All the patients in this study will receive pegylated interferon for all course.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hepatitis B surface antigen | up to 48 weeks | hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hepatitis B surface antibody | up to 48 weeks | hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml. |
Countries
China
Outcome results
None listed