Clinical trial NCT04035837: The Clinical Cure Project of Chronic Hepatitis B in China
Official title: A Study of Peg-interferon Treatment for Nucleos(t)Ide Analogues Suppressed Chronic Hepatitis B Patients With Low Level Hepatitis Surface Antigen
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: hepatitis B surface antigen
timeFrame: up to 48 weeks
Secondary outcomes:
measure: hepatitis B surface antibody
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Zhiliang Gao
role: STUDY_CHAIR
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