Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b
NCT ID: NCT04195074
Last Updated: 2019-12-17
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
300 participants
INTERVENTIONAL
2019-01-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ETV group
100 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
Entecavir
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
TDF group
100 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
Tenofovir Disoproxil Fumarate
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
TAF group
100 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.
Tenofovir Alafenamide
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Interventions
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Entecavir
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Tenofovir Disoproxil Fumarate
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Tenofovir Alafenamide
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age from 18 to 65 years old;
3. HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
4. ALT≥2×ULN；
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.
Exclusion Criteria
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Using glucocorticoid;
8. Patients can not follow-up;
9. Investigator considering inappropriate.
18 Years
65 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Liang Peng
Professer
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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Liang Peng, Doctor
Role: primary
Other Identifiers
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PL8
Identifier Type: -
Identifier Source: org_study_id