TAF Real World Study for Universal Effectiveness
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A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
1 other identifier
observational
500
1 country
7
Brief Summary
This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating 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 other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
November 26, 2018
CompletedStudy Start
First participant enrolled
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedNovember 26, 2019
November 1, 2019
4.3 years
November 20, 2018
November 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
proportion of participants with HBV DNA < 20 IU/mL
proportion of participants with HBV DNA \< 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months
36 months
Secondary Outcomes (12)
The proportion of patients with HBV DNA < 20 IU/mL
12 months
The proportion of patients with HBV DNA <300 copies/mL
12 months
The proportion of patients with HBV DNA < 20 IU/mL
24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
36 months
- +7 more secondary outcomes
Study Arms (1)
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.
Interventions
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
Eligibility Criteria
Males and non-pregnant, non-lactating female patients with HBsAg positive \> 6 months above 18 years of age; Documented evidence of chronic HBV infection previously; HBV mono-infected HBeAg positive or negative; NA treatment-naive and treatment-experienced; TAF naive; Agree to participate in the study and sign the patient informed consent. Subjects coinfected with HCV, hepatitis D virus (HDV), human immunodeficiency virus (HIV) or who have received TAF or who haveChild-Pugh C decompensated liver disease or HCC will be excluded.
You may qualify if:
- Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures
- Adult males and nonpregnant, nonlactating females
- Documented evidence of chronic HBV infection previously
- TAF naive
You may not qualify if:
- Patents who were TAF experienced
- Women who are breastfeeding
- Pregnant females
- Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- 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)
- Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis)
- Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy
- Abnormal hematological and biochemical parameters, including:
- Albumin \< 2.8 mg/ dL
- International normalized ratio (INR) \> 2.3 X ULN (unless stable on anticoagulant regimen)
- Total bilirubin \> 3 X ULN
- Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
- Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation
- 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.
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
- Gilead Sciencescollaborator
Study Sites (7)
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, 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
Biospecimen
Serum, urine and whole blood will be restored in central lab
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qin Ning, MD., Ph.D.
Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 20, 2018
First Posted
November 26, 2018
Study Start
January 25, 2019
Primary Completion
May 1, 2023
Study Completion
September 1, 2023
Last Updated
November 26, 2019
Record last verified: 2019-11