New Strategy Study of Functional Cure of Chronic Hepatitis B
A Study on Optimizing HBsAg Clearance in CHB Patients With Sequential Treatment of Pegylated Interferon Alpha-2b and Nucleoside Analogues
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2015
CompletedFirst Posted
Study publicly available on registry
November 16, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedSeptember 20, 2016
September 1, 2016
1.5 years
November 8, 2015
September 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBsAg loss
Week 48
Study Arms (1)
CHB patients
EXPERIMENTALHepatitis 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The third affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiang Zhu, Doctor
Third Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
November 8, 2015
First Posted
November 16, 2015
Study Start
March 1, 2016
Primary Completion
September 1, 2017
Last Updated
September 20, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share