- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745704
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
January 12, 2019 updated by: Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg
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.
Study Overview
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 for 48 weeks and follow up for 24 weeks.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510630
- Recruiting
- The Third Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Xiang Zhu, Doctor
- Phone Number: 13826452564
- Email: 0628zhuxiang@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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(Roche Cobas).
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEG-IFN group
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-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.
|
peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week
|
No Intervention: NAs group
Patients do not need to change their NAs treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HBsAg Clearance
Time Frame: 72 weeks
|
Percentage of Participants with HBsAg negative.
|
72 weeks
|
HBsAg Seroconversion
Time Frame: 72 weeks
|
Percentage of Participants with HBsAg negative and anti-HBsAg positive.
|
72 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
April 1, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
April 11, 2016
First Submitted That Met QC Criteria
April 17, 2016
First Posted (Estimate)
April 20, 2016
Study Record Updates
Last Update Posted (Actual)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 12, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- 3rd-SYSU-I-Cure
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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