The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg
NCT ID: NCT02893124
Last Updated: 2018-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2016-08-31
2019-08-31
Brief Summary
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Detailed Description
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After giving informed consent, patients were treated with NAs once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.
In this study, treatment endpoint was HBsAg loss(\<0.05 IU/mL).Anti-HBs positive(\>10 milli-International unit)(mIU/mL) defined as seroconversion. 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 case of nonresponse.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEG-IFN group
HBeAg-negative CHB patients with HBsAg \<1000 IU/ mL and HBV DNA\<100 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.
peginterferon alfa
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
NAs group
CHB patients do not need to change their NAs treatment.
No interventions assigned to this group
Interventions
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peginterferon alfa
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Hepatitis B e antigen (HBeAg)-negative.
3. Hepatitis B surface antigen (HBsAg) positive and \<1000 IU/mL.
4. Hepatitis B virus DNA \<100 IU/mL.
Exclusion Criteria
2. Patients with other factors causing liver diseases.
3. Pregnant and lactating women.
4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
5. Patients with diabetes, autoimmune diseases.
6. Patients with important organ dysfunctions.
7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
9. Patients with a previous use of IFN anti hepatitis B virus treatment.
10. Patients who can't come back to clinic for follow-up on schedule.
18 Years
65 Years
ALL
No
Sponsors
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Peking University
OTHER
Huazhong University of Science and Technology
OTHER
Nanchang University
OTHER
Huizhou Municipal Central Hospital
OTHER
First People's Hospital, Shunde China
OTHER
Shenzhen Third People's Hospital
OTHER
First People's Hospital of Foshan
OTHER
Tang-Du Hospital
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Yuebei People's Hospital
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Zhiliang Gao
Chief director of department of infectious disease
Locations
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Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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I-Cure-3
Identifier Type: -
Identifier Source: org_study_id
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