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
500 participants
OBSERVATIONAL
2019-01-25
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tenofovir alafenamide (TAF)
Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents.
Tenofovir Alafenamide
The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
Interventions
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Tenofovir Alafenamide
The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adult males and nonpregnant, nonlactating females
3. Documented evidence of chronic HBV infection previously
4. TAF naive
Exclusion Criteria
2. Women who are breastfeeding
3. Pregnant females
4. Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
5. Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is \< 50 ng/mL no imaging study is needed; however, if the screening AFP is \> 50 ng/mL an imaging study is required)
6. Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis)
7. Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy
8. Abnormal hematological and biochemical parameters, including:
9. Albumin \< 2.8 mg/ dL
10. International normalized ratio (INR) \> 2.3 X ULN (unless stable on anticoagulant regimen)
11. Total bilirubin \> 3 X ULN
12. Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
13. Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation
14. Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
15. Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
16. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
17. Use of investigational agents within 3 months of screening, unless allowed by the sponsor
18. Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
19. Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
20. Inability or unwillingness to provide informed consent or abide by the requirements of the study
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Tongji Hospital
OTHER
Responsible Party
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Qin Ning
Director
Principal Investigators
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Qin Ning, MD., Ph.D.
Role: STUDY_CHAIR
Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Shulan(Hangzhou) hospitai
Hangzhou, , China
First Affiliated Hospital of Nanchang University
Nanchang, , China
Shanghai public health clinic
Shanghai, , China
General Hospital of The Yangtze River Shipping
Wuhan, , China
The Seventh Hospital of Wuhan
Wuhan, , China
Xiangya Hospital of Central South University
Xiangya, , China
Countries
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Central Contacts
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Facility Contacts
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Zhe Yu
Role: primary
Xiaoping Wu, Doctor
Role: primary
Liang Chen
Role: primary
Lvye Xu
Role: primary
Youqin Yan
Role: primary
Yan Huang
Role: primary
Other Identifiers
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IN-US-320-4669
Identifier Type: -
Identifier Source: org_study_id
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