The Clinical Cure Project of Chronic Hepatitis B in China

Sun Yat-sen University

Status and phase: Enrolling; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: pegylated interferon-alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT04035837

ZhuFeng Project

Details and patient eligibility

About

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.

Enrollment: 30,000 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30,000 participants in 3 patient groups

short-course combination group

Experimental group

Description:

Nucleoside analogue is used during the first 3 months.

Treatment:

Drug: pegylated interferon-alfa

full-course combination group

Experimental group

Description:

Nucleoside analogue is used during all the course of study.

Treatment:

Drug: pegylated interferon-alfa

Monotherapy group

Experimental group

Description:

Only Peg-IFN is used during all the course of study.

Treatment:

Drug: pegylated interferon-alfa