Status:
UNKNOWN
TAF Real World Study for Universal Effectiveness
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Gilead Sciences
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
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, e...
Detailed Description
This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
- Use of investigational agents within 3 months of screening, unless allowed by the sponsor
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF
Key Trial Info
Start Date :
January 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03752658
Start Date
January 25 2019
End Date
September 1 2023
Last Update
November 26 2019
Active Locations (7)
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1
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
2
Shulan(Hangzhou) hospitai
Hangzhou, China
3
First Affiliated Hospital of Nanchang University
Nanchang, China
4
Shanghai public health clinic
Shanghai, China