Back to resultsEfficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss
Primary Purpose
Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Entecavir
Peginterferon alfa-2a
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis B, sequential peg-interferon-2a to entecavir
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 50 years old
- HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
- Treated by entacavir for 48 weeks with HBeAg seroconversion
Exclusion Criteria:
- Pregnant women
- Decompensated liver disease
- Combination infection of HCV, HAV, or HEV
- Combination infection of HIV
- Any contraindication of interferon α
Sites / Locations
- The Third Affliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
entecavir
peg-interferon
Arm Description
patients continue to use entecavir
patients switch to sequential peg-interferon α-2a
Outcomes
Primary Outcome Measures
HBeAg sericonversion rate
Secondary Outcome Measures
HBeAg loss rate
HBeAg quantification dynamic change
HBsAg loss rate
HBsAg seroconversion rate
HBsAg quantification dynamic change
ALT normalization rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01599130
Brief Title
Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss
Official Title
The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
Detailed Description
For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B, sequential peg-interferon-2a to entecavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
entecavir
Arm Type
Active Comparator
Arm Description
patients continue to use entecavir
Arm Title
peg-interferon
Arm Type
Experimental
Arm Description
patients switch to sequential peg-interferon α-2a
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude
Intervention Description
entecavir 0.5mg per day
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pagasys
Intervention Description
Peginterferon alfa-2a 180ug per week
Primary Outcome Measure Information:
Title
HBeAg sericonversion rate
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
HBeAg loss rate
Time Frame
72 weeks
Title
HBeAg quantification dynamic change
Time Frame
72 weeks
Title
HBsAg loss rate
Time Frame
72 weeks
Title
HBsAg seroconversion rate
Time Frame
72 weeks
Title
HBsAg quantification dynamic change
Time Frame
72 weeks
Title
ALT normalization rate
Time Frame
72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 50 years old
HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
Treated by entacavir for 48 weeks with HBeAg seroconversion
Exclusion Criteria:
Pregnant women
Decompensated liver disease
Combination infection of HCV, HAV, or HEV
Combination infection of HIV
Any contraindication of interferon α
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiliang Gao
Organizational Affiliation
The Third Affliated Hospital of Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufeng Zhang, master
Phone
+862085253333
Email
zhanlianh@163.com
Phone
+862085253333
First Name & Middle Initial & Last Name & Degree
Zhiliang Gao, doctor
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss
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