TAF Real World Study for Universal Effectiveness (TRUE)

A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: Tenofovir Alafenamide

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Qin Ning, MD., Ph.D.; Phone Number: +86 278366 2391; Email: qning@vip.sina.com
• Study Contact Backup: Name: Di Wu, MD., Ph.D.; Phone Number: +86 278366 2391; Email: woody_1984@163.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Shulan(Hangzhou) hospitai
    • Contact: Zhe Yu
    • Principal Investigator: Zhe Yu
  • Nanchang, China
    • Recruiting
    • First Affiliated Hospital of Nanchang University
    • Contact: Xiaoping Wu, Doctor
  • Shanghai, China
    • Recruiting
    • Shanghai public health clinic
    • Contact: Liang Chen
    • Principal Investigator: Liang Chen
  • Wuhan, China
    • Not yet recruiting
    • General Hospital of The Yangtze River Shipping
    • Contact: Lvye Xu
    • Principal Investigator: Lvye Xu
  • Wuhan, China
    • Recruiting
    • The Seventh Hospital of Wuhan
    • Contact: Youqin Yan
    • Principal Investigator: Youqin Yan
  • Xiangya, China
    • Recruiting
    • Xiangya Hospital of Central South University
    • Principal Investigator: Yan Huang
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Not yet recruiting
      • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qin Ning, Prof.; Phone Number: 862883662391; Email: qning@vip.sina.com
      • Principal Investigator: Qin Ning, Doctor
      • Principal Investigator: Di Wu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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 Names: Vemlidy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with HBV DNA < 20 IU/mL	The proportion of patients with HBV DNA < 20 IU/mL at 12 months	12 months
The proportion of patients with HBV DNA <300 copies/mL	The proportion of patients with HBV DNA <300 copies/mL at 12 months	12 months
The proportion of patients with HBV DNA < 20 IU/mL	The proportion of patients with HBV DNA < 20 IU/mL at 24 months	24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL	The proportion of patients with HBV DNA <300 copies/mL at 24 months	24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL	The proportion of patients with HBV DNA <300 copies/mL at 36 months	36 months
Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss	Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months	36 months
Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)	Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months	36 months
Proportion of participants with Normal Alanine Aminotransferase (ALT)	Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months	36 months
Change from baseline in fibrosis as assessed by Fibroscan®	Change from baseline in fibrosis as assessed by Fibroscan® at 36 months	36 months
Percent Change from baseline in Bone Mineral Density (BMD)	Percent Change from baseline in Bone Mineral Density (BMD) at 36 months	36 months
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)	Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months	36 months
the rate of mother-to-child transmission of HBV	For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate	at postpartum 6 months

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Gilead Sciences
• Investigators: Study Chair: Qin Ning, MD., Ph.D., Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis; Hepatitis B, Chronic; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: IN-US-320-4669

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No