Back to resultsNew Strategy Study of Functional Cure of Chronic Hepatitis B
Primary Purpose
Hepatitis B, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Peginterferon alfa-2b
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Chronic hepatitis B, Peginterferon alfa-2b, Nucleotide analogue
Eligibility Criteria
Inclusion Criteria:
- CHB patients who had received NAs for more than 12 months.
- Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
- Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
- Hepatitis B virus DNA not detectable.
Exclusion Criteria:
- 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 serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. )
- 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.
Sites / Locations
- The third affiliated hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CHB patients
Arm Description
Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks.
Outcomes
Primary Outcome Measures
HBsAg loss
Secondary Outcome Measures
Full Information
NCT ID
NCT02605252
First Posted
November 8, 2015
Last Updated
September 19, 2016
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02605252
Brief Title
New Strategy Study of Functional Cure of Chronic Hepatitis B
Official Title
A Study on Optimizing HBsAg Clearance in CHB Patients With Sequential Treatment of Pegylated Interferon Alpha-2b and Nucleoside Analogues
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)
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
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-2b and NAs.
Detailed Description
CHB Patients who had received, and responded to, NAs for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Chronic hepatitis B, Peginterferon alfa-2b, Nucleotide analogue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CHB patients
Arm Type
Experimental
Arm Description
Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2b
Intervention Description
peginterferon alfa-2b 80 micrograms/week for 48 weeks
Primary Outcome Measure Information:
Title
HBsAg loss
Time Frame
Week 48
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 NAs for more than 12 months.
Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
Hepatitis B virus DNA not detectable.
Exclusion Criteria:
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 serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. )
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Zhu, Doctor
Phone
+86-20-85252373
Email
0628zhuxiang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Zhu, 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
No
Learn more about this trial
New Strategy Study of Functional Cure of Chronic Hepatitis B
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