TAF Real World Study for Universal Effectiveness

Chronic Hepatitis b Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03752658
• Other study ID #: IN-US-320-4669
• Status: Recruiting
• Start date: January 25, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2019
• Source: Tongji Hospital
• Contact: Qin Ning, MD., Ph.D.
• Phone: +86 278366 2391
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Shulan(Hangzhou) hospitai	Hangzhou
China	First Affiliated Hospital of Nanchang University	Nanchang
China	Shanghai public health clinic	Shanghai
China	Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	General Hospital of The Yangtze River Shipping	Wuhan
China	The Seventh Hospital of Wuhan	Wuhan
China	Xiangya Hospital of Central South University	Xiangya

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	Gilead Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of participants with Normal Alanine Aminotransferase (ALT)	Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months	36 months
Secondary	Change from baseline in fibrosis as assessed by Fibroscan®	Change from baseline in fibrosis as assessed by Fibroscan® at 36 months	36 months
Secondary	Percent Change from baseline in Bone Mineral Density (BMD)	Percent Change from baseline in Bone Mineral Density (BMD) at 36 months	36 months
Secondary	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
Secondary	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