To Optimize the Therapeutic Pathway of Peginterferon Treatment in Patients With CHB Based on IFNA2p.Ala120Thr /ISGs. (IFNA2/ISGs)
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|ClinicalTrials.gov Identifier: NCT03771677|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Drug: Nucleotide Analog Drug: Interferon Alfa-2A||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Drug: nucleotide analogues(NAs)
Drug: Peginterferon alfa-2a
|Masking:||None (Open Label)|
Active Comparator:nucleotide analogues(NAs) patients continue to use NAs
Experimental: peg-interferon alfa-2a patients switch to sequential peg-interferon α-2a
|Official Title:||A Multicenter Clinical Study to Optimize the Therapeutic Pathway of Peginterferon Alfa-2b Treatment in Patients With Chronic Hepatitis B Based on IFNA2p.Ala120Thr /ISGs Gene Spectrum.|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||December 30, 2024|
Active Comparator: Active Comparator:NAs group
Active Comparator:nucleotide analogues(NAs)
patients continue to use NAs
Drug: Nucleotide Analog
such as Entecavir,entecavir 0.5mg per day
Other Name: Nucleotide Analogs
Experimental: Experimental:PEG-IFN group
Experimental: peg-interferon alfa-2a
patients switch to sequential peg-interferon α-2a
Drug: Interferon Alfa-2A
Peginterferon alfa-2a 180ug per week
Other Name: Pegasys
- HBsAg clearance rate [ Time Frame: 48 weeks ]Whether the HBsAg clearance rate of patients who received interferon treatment was higher than those treated with nucleoside drugs.
- HBV cccDNA and pgRNA quantification dynamic change [ Time Frame: 48 weeks ]The difference in cccDNA and pgRNA clearance rate between the two groups after 48 weeks of treatment in immune-controlled patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771677
|Contact: Chan Xie, Professorfirstname.lastname@example.org|
|Guangzhou, Guangdong, China, 510000|
|Contact: Chan Xie, Professor 862085252043 email@example.com|
|Principal Investigator:||Chan Xie||The Third Affliated Hospital of Sun Yat-sen University|