Optimized Treatment of Peginterferon Alfa 2a/2b in Treatment Experienced Patients With HBV Related Liver Fibrosis
NCT ID: NCT03920605
Last Updated: 2019-05-22
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
NA
100 participants
INTERVENTIONAL
2019-02-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peginterferon alfa group
50 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.
Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Peginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Combination group
50 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week and meanwhile oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive treatment of oral TDF 300 mg once per day from 49 to 144 weeks.
Tenofovir Disoproxil Fumarate
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Peginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Interventions
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Tenofovir Disoproxil Fumarate
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Peginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age from 18 to 55 years old;
3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
4. Portal vein diameter ≤ 12 mm from liver ultrasound;
5. Receiving treatment of nucleoside/nucleotide analogues at the past one year;
6. Normal liver function;
7. Undetectable hepatitis b virus DNA.
Exclusion Criteria
2. Pregnancy or lactation;
3. Other active liver diseases；
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Patients can not follow-up;
8. Investigator considering inappropriate.
15 Years
55 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Liang Peng
Professor
Principal Investigators
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Liang Peng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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Third Affiliated 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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PL5
Identifier Type: -
Identifier Source: org_study_id
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