To Optimize the Therapeutic Pathway of Peginterferon Treatment in Patients With CHB Based on IFNA2p.Ala120Thr /ISGs.
NCT ID: NCT03771677
Last Updated: 2023-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2018-12-01
2024-12-30
Brief Summary
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Detailed Description
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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 informed consent , patients were grouped according to their treatment intentions,in one group, patients continued NAs for another 48 weeks. In another group , patients were treated with peg-interferon-2a and NAs 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, we will analyze whether clinical cure rates differed between patients with chronic hepatitis B treated with peginterferon alfa-2a and NAs;Bisedes,the baseline interferon variant site variants and changes in interferon-stimulated gene profile expression were analyzed to determine whether they could be used as molecular markers to predict clinical cure with interferon.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Drug: Peginterferon alfa-2a and nucleotide analogues(NAs)
TREATMENT
NONE
Experimental: peg-interferon alfa-2a patients switch to sequential peg-interferon α-2a
Study Groups
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Active Comparator:NAs group
Active Comparator:nucleotide analogues(NAs)
patients continue to use NAs
Nucleotide Analog
such as Entecavir,entecavir 0.5mg per day
Experimental:PEG-IFN group
Experimental: peg-interferon alfa-2a
patients use peg-interferon α-2a and nucleotide analogues(NAs)
Nucleotide Analog
such as Entecavir,entecavir 0.5mg per day
Interferon Alfa-2A
Peginterferon alfa-2a 180ug per week
Interventions
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Nucleotide Analog
such as Entecavir,entecavir 0.5mg per day
Interferon Alfa-2A
Peginterferon alfa-2a 180ug per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HBsAg positive, HBsAg quantification≤1500 IU/mL;
* Serum HBV DNA quantification \<100 IU/mL;
* HBeAg negative.
Exclusion Criteria
* Liver cirrhosis or HCC and other associated tumors;
* Women during pregnancy or lactation;
* With liver disease caused by other causes;
* Combination infection of HIV or other immunodeficiency diseases;
* With diabetes, autoimmune diseases and other organ dysfunction or failure;
* Combination of other serious complications (infection, hepatic encephalopathy,gastrointestinal bleeding, hepatorenal syndrome, etc.);
* Others who cannot be treated with interferon;
* Anyone cannot return to the hospital for follow-up and follow-up visits regularly as planned
18 Years
60 Years
ALL
No
Sponsors
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First People's Hospital of Foshan
OTHER
Eighth Affiliated Hospital, Sun Yat-sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Chan Xie
Professor of department of infectious disease Third Affiliated Hospital,Sun Yat-Sen University
Principal Investigators
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Chan Xie
Role: PRINCIPAL_INVESTIGATOR
The Third Affliated Hospital of Sun Yat-sen University
Locations
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Chan Xie
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XC1
Identifier Type: -
Identifier Source: org_study_id
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