Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-28 @ 12:10 PM
Study NCT ID:
NCT04034368
Status:
UNKNOWN
Last Update Posted:
2019-07-26
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir
Sponsor:
The First Hospital of Jilin University
Organization:
Study Overview
Official Title:
A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) or Intolerant to Entecavir
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_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:
None
Brief Summary:
This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?: