Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-18 @ 12:15 AM
Study NCT ID:
NCT03752658
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2018-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAF Real World Study for Universal Effectiveness
Sponsor:
Tongji Hospital
Organization:
Study Overview
Official Title:
A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUE
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: