search
Back to results

HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
peginterferon alfa
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 Alpha

Eligibility Criteria

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

Inclusion Criteria:

  1. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
  2. Hepatitis B surface antibody (HBsAb) negative.
  3. Hepatitis B e antigen (HBeAg) negative.
  4. Hepatitis B virus DNA <2000 IU/mL.
  5. Absence of previous antiviral therapy.

Exclusion Criteria:

  1. Patients with active alcohol and/or drugs consumption.
  2. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
  3. Patients with other factors causing liver diseases.
  4. Pregnant and lactating women.
  5. Patients with concomitant HIV infection or congenital immune deficiency diseases.
  6. Patients with diabetes, autoimmune diseases.
  7. Patients with important organ dysfunctions.
  8. Patients with mental illness.
  9. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
  10. Patients who can't come back to clinic for follow-up on schedule.

Sites / Locations

  • Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pegylated interferon group

Observing Group

Arm Description

Low replicative chronic HBV infection patients with HBsAg <1000 IU/ mL and HBV DNA<2000 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.

Only observing and following up in this group.

Outcomes

Primary Outcome Measures

HBsAg Clearance Rate
Percentage of Participants with HBsAg negative.

Secondary Outcome Measures

HBsAg Seroconversion Rate
Percentage of Participants with HBsAg negative and anti-HBsAg positive

Full Information

First Posted
August 27, 2016
Last Updated
May 20, 2018
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
Peking University, Huazhong University of Science and Technology, Nanchang University, Huizhou Municipal Central Hospital, First People's Hospital, Shunde China, Shenzhen Third People's Hospital, First People's Hospital of Foshan, Tang-Du Hospital, First Affiliated Hospital of Kunming Medical University, Yuebei People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02908763
Brief Title
HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients
Official Title
HBsAg Loss/Seroconversion in Low Replicative Chronic HBV Infection Patients With Low Level HBsAg Treated With Peginterferon Alpha
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 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, Huazhong University of Science and Technology, Nanchang University, Huizhou Municipal Central Hospital, First People's Hospital, Shunde China, Shenzhen Third People's Hospital, First People's Hospital of Foshan, Tang-Du Hospital, First Affiliated Hospital of Kunming Medical University, Yuebei People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level HBsAg.
Detailed Description
Low replicative chronic HBV infection patients with low Level HBsAg were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA<2000 IU/mL and HBsAg levels ≤1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy. After giving informed consent, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study. In this study, treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 milli-International unit(mIU)/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels.

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 Alpha

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
Pegylated interferon group
Arm Type
Experimental
Arm Description
Low replicative chronic HBV infection patients with HBsAg <1000 IU/ mL and HBV DNA<2000 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.
Arm Title
Observing Group
Arm Type
No Intervention
Arm Description
Only observing and following up in this group.
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa
Other Intervention Name(s)
peginterferon alfa-2a or peginterferon alfa-2b
Intervention Description
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
Primary Outcome Measure Information:
Title
HBsAg Clearance Rate
Description
Percentage of Participants with HBsAg negative.
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
HBsAg Seroconversion Rate
Description
Percentage of Participants with HBsAg negative and anti-HBsAg positive
Time Frame
96 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: Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL. Hepatitis B surface antibody (HBsAb) negative. Hepatitis B e antigen (HBeAg) negative. Hepatitis B virus DNA <2000 IU/mL. Absence of previous antiviral therapy. Exclusion Criteria: Patients with active alcohol and/or drugs consumption. Patients with liver cirrhosis, Hepatocellular Carcinoma 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 mental illness. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. Patients who can't come back to clinic for follow-up on schedule.
Facility Information:
Facility Name
Department of Infectious Diseases, The Third Affliated 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
Zhi-Liang Gao, Professor
Phone
86-20-85252373
Email
zhilianggao@21cn.com
First Name & Middle Initial & Last Name & Degree
Xiang Zhu, Doctor
Phone
86-20-85252372
Email
0628zhuxiang@163.com
First Name & Middle Initial & Last Name & Degree
Zhi-Liang Gao, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients

We'll reach out to this number within 24 hrs