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Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

Primary Purpose

Chronic Hepatitis b

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir or Tenofovir
Peginterferon Alfa-2B
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b focused on measuring chronic hepatitis b, peginterferon alfa-2b, interferon gene mutation, interferon receptor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy;
  2. Hepatitis B e antigen positive.

Exclusion Criteria:

  1. Patients received anti-HBV therapy in the past 6 months;
  2. Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;
  3. Patients with other factors causing active liver diseases;
  4. Pregnancy or lactation women;
  5. Patients with HIV infection or congenital immune deficiency diseases;
  6. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
  7. Patients with other reasons not suitable to receive interferon therapy.

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nucleos(t)ide analogues treatment

Peginterferon treatment

Arm Description

Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.

Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.

Outcomes

Primary Outcome Measures

good virologic response
level of HBsAg is less than or equal to 1500 IU/ml

Secondary Outcome Measures

common virologic response
level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml
bad virologic response
level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml

Full Information

First Posted
November 13, 2016
Last Updated
November 23, 2016
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02973646
Brief Title
Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection
Official Title
Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.
Detailed Description
Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex, symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also observed the laboratory test results including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
chronic hepatitis b, peginterferon alfa-2b, interferon gene mutation, interferon receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nucleos(t)ide analogues treatment
Arm Type
Experimental
Arm Description
Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.
Arm Title
Peginterferon treatment
Arm Type
Active Comparator
Arm Description
Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.
Intervention Type
Drug
Intervention Name(s)
Entecavir or Tenofovir
Other Intervention Name(s)
Baraclude, Viread
Intervention Description
Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2B
Primary Outcome Measure Information:
Title
good virologic response
Description
level of HBsAg is less than or equal to 1500 IU/ml
Time Frame
24th week
Secondary Outcome Measure Information:
Title
common virologic response
Description
level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml
Time Frame
24th week
Title
bad virologic response
Description
level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml
Time Frame
24th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy; Hepatitis B e antigen positive. Exclusion Criteria: Patients received anti-HBV therapy in the past 6 months; Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies; Patients with other factors causing active liver diseases; Pregnancy or lactation women; Patients with HIV infection or congenital immune deficiency diseases; Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications. Patients with other reasons not suitable to receive interferon therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxiong Xu, Master
Phone
+8613760783281
Email
xwx1983@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

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