Back to resultsOptimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
Primary Purpose
Chronic Hepatitis b, Efficacy, Self
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Interferon Alfa 2a
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis b focused on measuring Chronic Hepatitis B, entecavir
Eligibility Criteria
Inclusion Criteria:
- Hepatitis b virus DNA or HBsAg positive for over half a year;
- Age from 18 to 65;
- With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease > 2 lg from baseline .
- Not be treated with interferon alfa ever before.
Exclusion Criteria:
- Other active liver diseases;
- Cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
- Other important organ dysfunctions;
- Patients can not follow-up.
Sites / Locations
- Third Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Tenofovir
Interferon alfa
Arm Description
Patents are treated with oral tenofovir 300mg once per day for 48 weeks. Then, tenofovir will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be continued if HBsAg is positive.
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
Outcomes
Primary Outcome Measures
HBsAg decrease after 48 weeks treatment
The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline.
Secondary Outcome Measures
HBsAg clearance after 48 weeks treatment
The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg clearance which is lower than 0.05 IU/ml.
Undetectable hepatitis b virus DNA after 48 weeks treatment
The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of hepatitis b virus DNA will be tested again. The investigators want to know the rate of patients with undetectable hepatitis b virus DNA which is lower than 20 IU/ml.
Full Information
NCT ID
NCT03733652
First Posted
November 6, 2018
Last Updated
November 20, 2018
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT03733652
Brief Title
Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
Official Title
Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
Detailed Description
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases > 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b, Efficacy, Self
Keywords
Chronic Hepatitis B, entecavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir
Arm Type
No Intervention
Arm Description
Patents are treated with oral tenofovir 300mg once per day for 48 weeks. Then, tenofovir will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be continued if HBsAg is positive.
Arm Title
Interferon alfa
Arm Type
Active Comparator
Arm Description
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
Intervention Type
Drug
Intervention Name(s)
Interferon Alfa 2a
Other Intervention Name(s)
Pegasys
Intervention Description
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
Primary Outcome Measure Information:
Title
HBsAg decrease after 48 weeks treatment
Description
The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
HBsAg clearance after 48 weeks treatment
Description
The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg clearance which is lower than 0.05 IU/ml.
Time Frame
48 weeks
Title
Undetectable hepatitis b virus DNA after 48 weeks treatment
Description
The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of hepatitis b virus DNA will be tested again. The investigators want to know the rate of patients with undetectable hepatitis b virus DNA which is lower than 20 IU/ml.
Time Frame
48 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 virus DNA or HBsAg positive for over half a year;
Age from 18 to 65;
With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease > 2 lg from baseline .
Not be treated with interferon alfa ever before.
Exclusion Criteria:
Other active liver diseases;
Cirrhosis, hepatocellular carcinoma or other malignancy;
Pregnancy or lactation;
Human immunodeficiency virus infection or congenital immune deficiency diseases;
Severe diabetes, autoimmune diseases;
Other important organ dysfunctions;
Patients can not follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxiong Xu, Doctor
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
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
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