The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
NCT ID: NCT02745704
Last Updated: 2019-01-15
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
2016-04-30
2019-04-30
Brief Summary
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Detailed Description
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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
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
peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week
NAs group
Patients do not need to change their NAs treatment.
No interventions assigned to this group
Interventions
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Peginterferon alfa
peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week
Eligibility Criteria
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Inclusion Criteria
2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
3. Hepatitis B surface antigen (HBsAg) positive and \<1500 IU/mL.
4. Hepatitis B virus DNA not detectable(Roche Cobas).
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 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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The third affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Facility Contacts
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Other Identifiers
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3rd-SYSU-I-Cure
Identifier Type: -
Identifier Source: org_study_id
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