The Clinical Cure Project of Chronic Hepatitis B in China

Condition(s) studied

Investigational drug(s) / intervention(s)

pegylated interferon-alfa: All the patients in this study will receive pegylated interferon for all course.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Third Affiliated Hospital, Sun Yat-Sen University trials in China

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