The Optimizing Treatment of Peginterferon Alpha in Chronic Hepatitis B Patients With Low Level HBsAg
1 other identifier
interventional
200
1 country
1
Brief Summary
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week for 12 weeks. At week 12, the decrease of HBsAg was evaluated. ①If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(\<0.05 IU/ mL). Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. After treatment, all patients were followed up for 48 weeks. ②If the decrease of HBsAg is less than 50% compared to baseline level. The combination therapy of NAs and peginterferon alfa was extended to week 24. Then, the decrease of HBsAg was evaluated again. If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(\<0.05 IU/mL). Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. After treatment, all patients were followed up for 48 weeks. If the decrease of HBsAg is less than 50% compared to baseline level. Peginterferon alfa was stopped, patients were treated with NAs once a day and then followed up for 48 weeks. Patients who maintained the original NAs treatment served as a control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2019
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
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 9, 2019
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 15, 2019
January 1, 2019
1.9 years
January 9, 2019
January 12, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
HBsAg Clearance
Participants with HBsAg \<0.05 IU/mL.
96 weeks
HBsAg Seroconversion
Participants with HBsAg \<0.05 IU/mL and anti-HBsAg positive
96 weeks
Study Arms (2)
PEG-IFN group
EXPERIMENTALpatients were treated with NAs once a day and PEG-IFN once a week for 12 weeks. At week 12, the decrease of HBsAg was evaluated. ①If the decrease of HBsAg is more than 50%. NAs was stopped. PEG-IFN Treatment was continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. ②If the decrease of HBsAg is less than 50%.NAs and PEG-IFN was extended to week 24. Then, If the decrease of HBsAg is more than 50%. NAs was stopped, PEG-IFN Treatment was continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. If the decrease of HBsAg is less than 50%. PEG-IFN was stopped, patients were treated with NAs once a day and then followed up for 48 weeks.
NAs group
OTHERCHB patients do not need to change their NAs treatment.
Interventions
Peginterferon Alfa-2A 180 micrograms/week or Peginterferon Alfa-2B 180 micrograms/week, for at most 96 weeks.
Patients do not need to change their NAs treatment.
Eligibility Criteria
You may qualify if:
- CHB patients who had received NAs for more than 12 months.
- Hepatitis B e antigen (HBeAg)-negative.
- Hepatitis B surface antigen (HBsAg) positive and \<1000 IU/mL.
- Hepatitis B virus DNA \<100 IU/mL.
You may not qualify if:
- Patients with liver cirrhosis, Hepatocellular Carcinoma or alpha feto protein (AFP) \>2 upper limit of normal(ULN) 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)
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhiliang Gao
Third Affiliated Hospital, Sun Yat-Sen University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 9, 2019
First Posted
January 11, 2019
Study Start
January 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
January 15, 2019
Record last verified: 2019-01