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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
Sponsor:
Collaborator:
First People's Hospital of Foshan
Information provided by (Responsible Party):
Chan Xie, Sun Yat-sen University

Brief Summary:
The study is to optimize the clinical therapeutic pathway of peginterferon alfa-2a treatment in patients with chronic hepatitis B based on the detection of interferon gene mutation (IFNA2p.Ala120Thr) and interferon-stimulated genes (ISGs) detection gene spectrum.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Nucleotide Analog Drug: Interferon Alfa-2A Not Applicable

Detailed 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Drug: nucleotide analogues(NAs)

Drug: Peginterferon alfa-2a

Masking: 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 α-2a

Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 65 years old;
  • HBsAg positive, HBsAg quantification≤1500 IU/mL;
  • Serum HBV DNA quantification <100 IU/mL;
  • HBeAg negative.

Exclusion Criteria:

  • Treated with interferon in the past six months;
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Chan Xie, Professor 862085252043 happyxiechan@hotmail.com

Locations
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China, Guangdong
Chan Xie Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Chan Xie, Professor    862085252043    happyxiechan@hotmail.com   
Sponsors and Collaborators
Sun Yat-sen University
First People's Hospital of Foshan
Investigators
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Principal Investigator: Chan Xie The Third Affliated Hospital of Sun Yat-sen University

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Responsible Party: Chan Xie, Professor of department of infectious disease Third Affiliated Hospital,Sun Yat-Sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03771677     History of Changes
Other Study ID Numbers: XC1
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chan Xie, Sun Yat-sen University:
Chronic Hepatitis B
IFNA2p.Ala120Thr /ISGs

Additional relevant MeSH terms:
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Interferon alpha-2
Interferon-alpha
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs