Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-22 @ 2:38 AM
Study NCT ID:
NCT05398393
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is a new second generation of tenofovir(TFV) and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.
Detailed Description:
In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is the phosphoramidite precursor of Tenofovir, belonging to the nucleoside reverse transcriptase and owning higher cell membrane penetration rate, which make it easier to enter hepatocytes and achieve liver-targeted therapy. Meanwhile, TMF can effectively improve drug stability in plasma and reduce systemic tenofovir(TFV) exposure, and make long-term treatment safer.
Previous studies have shown that tenofovir disoproxil (TDF), the first generation of TFV, had the effect of lowering blood lipids. While patients who switched to tenofovir alafenamide (TAF), the second generation of TFV, had elevated blood lipids. TMF is a new second generation of TFV and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.
Previous studies have shown that tenofovir disoproxil (TDF), the first generation of TFV, had the effect of lowering blood lipids. While patients who switched to tenofovir alafenamide (TAF), the second generation of TFV, had elevated blood lipids. TMF is a new second generation of TFV and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: