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The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
peginterferon alfa
Nucleoside analogues
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 peginterferon alfa, Chronic Hepatitis B

Eligibility Criteria

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

Inclusion Criteria:

  1. CHB patients who had received single NAs for more than 12 months.
  2. Hepatitis B e antigen (HBeAg)-negative.
  3. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
  4. Hepatitis B virus DNA <100 IU/mL.

Exclusion Criteria:

  1. Patients with liver cirrhosis, Hepatocellular Carcinoma or AFP >2 ULN or other malignancies.
  2. Patients with other factors causing liver diseases.
  3. Pregnant and lactating women.
  4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
  5. Patients with diabetes, autoimmune diseases.
  6. Patients with important organ dysfunctions.
  7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
  8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
  9. Patients with a previous use of IFN anti hepatitis B virus treatment or have NAs drug resistance.
  10. Patients who can't come back to clinic for follow-up on schedule.

Sites / Locations

  • The third affiliated hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1000 IU/mL and Hepatitis B virus DNA <100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.

Patients do not need to change their NAs treatment.

Outcomes

Primary Outcome Measures

HBsAg Clearance
Percentage of Participants with HBsAg <0.05 IU/mL.
HBsAg Seroconversion
Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2016
Last Updated
January 12, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
Peking University, Shenzhen Third People's Hospital, First People's Hospital of Foshan
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1. Study Identification

Unique Protocol Identification Number
NCT02838810
Brief Title
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
Official Title
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
Peking University, Shenzhen Third People's Hospital, First People's Hospital of Foshan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.
Detailed Description
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
peginterferon alfa, Chronic Hepatitis B

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1000 IU/mL and Hepatitis B virus DNA <100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.
Arm Title
Control
Arm Type
Other
Arm Description
Patients do not need to change their NAs treatment.
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa
Intervention Description
peginterferon alfa-2b or peginterferon alfa-2a
Intervention Type
Drug
Intervention Name(s)
Nucleoside analogues
Other Intervention Name(s)
NAs
Intervention Description
Nucleoside analogues
Primary Outcome Measure Information:
Title
HBsAg Clearance
Description
Percentage of Participants with HBsAg <0.05 IU/mL.
Time Frame
120 weeks
Title
HBsAg Seroconversion
Description
Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.
Time Frame
120 weeks

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: CHB patients who had received single NAs for more than 12 months. Hepatitis B e antigen (HBeAg)-negative. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL. Hepatitis B virus DNA <100 IU/mL. Exclusion Criteria: Patients with liver cirrhosis, Hepatocellular Carcinoma or AFP >2 ULN or other malignancies. Patients with other factors causing liver diseases. Pregnant and lactating women. Patients with concomitant HIV infection or congenital immune deficiency diseases. Patients with diabetes, autoimmune diseases. Patients with important organ dysfunctions. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.) Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. Patients with a previous use of IFN anti hepatitis B virus treatment or have NAs drug resistance. Patients who can't come back to clinic for follow-up on schedule.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Zhu, Doctor
Phone
13826452564
Email
0628zhuxiang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiliang Gao, 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
Xiang Zhu, Doctor
Phone
13826452564
Email
0628zhuxiang@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

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