Clinical trial NCT03752658: TAF Real World Study for Universal Effectiveness
Official title: A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis b
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2018-11-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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 safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. 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 other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures
2. Adult males and nonpregnant, nonlactating females
3. Documented evidence of chronic HBV infection previously
4. TAF naive

Exclusion Criteria:

1. Patents who were TAF experienced
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
21. In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF

Primary outcomes:
measure: proportion of participants with HBV DNA < 20 IU/mL
timeFrame: 36 months
Secondary outcomes:
measure: The proportion of patients with HBV DNA < 20 IU/mL
timeFrame: 12 months
measure: The proportion of patients with HBV DNA <300 copies/mL
timeFrame: 12 months
measure: The proportion of patients with HBV DNA < 20 IU/mL
timeFrame: 24 months
measure: The proportion of patients with HBV DNA <300 copies/mL IU/mL
timeFrame: 24 months
measure: The proportion of patients with HBV DNA <300 copies/mL IU/mL
timeFrame: 36 months
measure: Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss
timeFrame: 36 months
measure: Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)
timeFrame: 36 months
measure: Proportion of participants with Normal Alanine Aminotransferase (ALT)
timeFrame: 36 months
measure: Change from baseline in fibrosis as assessed by Fibroscan®
timeFrame: 36 months
measure: Percent Change from baseline in Bone Mineral Density (BMD)
timeFrame: 36 months
measure: Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
timeFrame: 36 months
measure: the rate of mother-to-child transmission of HBV
timeFrame: at postpartum 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Hangzhou
country: China
facility: Shulan(Hangzhou) hospitai
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Shanghai public health clinic
city: Wuhan
country: China
facility: General Hospital of The Yangtze River Shipping
city: Wuhan
country: China
facility: The Seventh Hospital of Wuhan
city: Xiangya
country: China
facility: Xiangya Hospital of Central South University
Study officials:
affiliation: Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Qin Ning, MD., Ph.D.
role: STUDY_CHAIR
References: