To Optimize the Therapeutic Pathway of Peginterferon Treatment in Patients With CHB Based on IFNA2p.Ala120Thr /ISGs.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatitis B
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Drug: nucleotide analogues(NAs) Drug: Peginterferon alfa-2aMasking: None (Open Label)Masking Description: Active Comparator:nucleotide analogues(NAs) patients continue to use NAs Experimental: peg-interferon alfa-2a patients switch to sequential peg-interferon ?-2aPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally.How to make more patients with chronic hepatitis B get clinical treatment through the existing anti-viral treatment is an urgent problem to be solved.This study is a random, multi-center and open exp...
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally.How to make more patients with chronic hepatitis B get clinical treatment through the existing anti-viral treatment is an urgent problem to be solved.This study is a random, multi-center and open experiment,the collaborators includes the second people's hospital of zhongshan city, the eighth people's hospital of guangzhou city, and the first people's hospital of foshan city. Patients with chronic hepatitis B who were treated with NAs for over 1 year,HBsAg quantification?1500 IU/mL, HBeAg negative and serum HBV DNA quantification <100 IU/mL were enrolled in this study. In our study, the enrolled patient's IFNA2p.Ala120Thr without variation and ISGs>0.05 were divided into two groups. After randomized grouping and giving informed consent,in one group, patients continued NAs for another 48 weeks. In another group , patients switched to peg-interferon-2a monotherapy for 48 weeks.Patient's BMI, genotype, family history, smoking history, drinking history, other medical history, suspected transmission channels, types and time of use were recorded in this study.Moreover, Patients were assessed every 12 weeks,included liver and kidney function, blood routine, HBV cccDNA, HBeAg quantification, HBsAg quantification, pgRNA and so on.In addition,liver imaging examination and liver hardness test were assessed every six months. In this study, the "accurate" and "individualized" selection of the long-term interferon anti-hbv treatment will be conducted. Before the treatment, "optimal patients" and "optimal treatment" are selected, in an attempt to improve the response rate and efficacy of interferon,which can improve the cure rate of hepatitis b,proceeding "Individualized" anti-hbv treatment more scientifically and precisely.
Tracking Information
- NCT #
- NCT03771677
- Collaborators
- First People's Hospital of Foshan
- Investigators
- Principal Investigator: Chan Xie The Third Affliated Hospital of Sun Yat-sen University
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