Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01597934
Status:
UNKNOWN
Last Update Posted:
2014-01-31
First Post:
2012-05-08
Brief Title:
Antiviral Efficacy of Switching to ETV Plus TDF
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Randomized Multicenter Prospective Study to Compare Antiviral Efficacy and Safety of Switching to ETV Plus TDF Versus Maintaining LAMLDT Plus ADF Combination in CHC With PVR to LAMLDF Plus ADF Combination Rescue Therapy for YMDD Mutation
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
ACTIVE_NOT_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:
Switching to EntecavirETV plus Tenofovir Disoproxil FumarateTDF combination will result in faster and greater antiviral activity and lower rates of resistance emergence over maintaining LamivudineLAMTelbivudineLdTAdefovirADV combination in partial responders to LAMLdTADV rescue therapy
Earlier switching to combination with the most potent regimen will be more effective to achieve virologic responseVR and prevent further resistance emergence
All subjects will orally take assigned drugs once daily for 48 weeks All subjects will be assessed at baseline and every three months thereafter Evaluations at each visit will include vital signs physical examinations laboratory tests HBV DNA levels and adverse events At baseline and every six months thereafter serum will be assayed for HBV serology Genotypic analysis will be performed at baseline and 48 weeks
Earlier switching to combination with the most potent regimen will be more effective to achieve virologic responseVR and prevent further resistance emergence
All subjects will orally take assigned drugs once daily for 48 weeks All subjects will be assessed at baseline and every three months thereafter Evaluations at each visit will include vital signs physical examinations laboratory tests HBV DNA levels and adverse events At baseline and every six months thereafter serum will be assayed for HBV serology Genotypic analysis will be performed at baseline and 48 weeks
Detailed Description:
1 As TDF has not been approved yet in Korea current KASL practice guideline generally recommends to add ADV in LAM-resistant or LdT-resistant patients
2 However several local literatures reported a substantial proportion of patients treated with LAM plus ADV combination therapy showed a persistently inadequate or partial virologic responseVR and YMDDm still maintained in spite of under rescue combination therapy
3 Due to the unavailability of TDF in Korea ETV plus ADV combination has being considered a better salvage therapy with non-overlapping cross-resistance profiles in pts who fail to LAM plus ADV rescue therapy and local report demonstrated that the rate of VR was significantly higher with ETVADV switching group than LAMADV continuation group in partial responder to LAM plus ADV combination rescue therapy for LAM resistance
4 Hence more earlier combination therapy with the most potent Nucleoside and Nucleotide analogue would be a promising salvage treatment for previous NA treatment failures but comparative prospective trials are limited
5 Therefore this study will investigate the greater effectiveness and safety of switching to the most potent combination versus maintaining LAMor LdT plus ADV and also compare the rate of VR based on the HBV DNA cut-off level at switching - more than and less than 20000 IUmL
All subjects will orally take assigned drugs once daily for 48 weeks All subjects will be assessed at baseline and every three months thereafter Evaluations at each visit will include vital signs physical examinations laboratory tests HBV DNA levels and adverse events At baseline and every six months thereafter serum will be assayed for HBV serology Genotypic analysis will be performed at baseline and 48 weeks
2 However several local literatures reported a substantial proportion of patients treated with LAM plus ADV combination therapy showed a persistently inadequate or partial virologic responseVR and YMDDm still maintained in spite of under rescue combination therapy
3 Due to the unavailability of TDF in Korea ETV plus ADV combination has being considered a better salvage therapy with non-overlapping cross-resistance profiles in pts who fail to LAM plus ADV rescue therapy and local report demonstrated that the rate of VR was significantly higher with ETVADV switching group than LAMADV continuation group in partial responder to LAM plus ADV combination rescue therapy for LAM resistance
4 Hence more earlier combination therapy with the most potent Nucleoside and Nucleotide analogue would be a promising salvage treatment for previous NA treatment failures but comparative prospective trials are limited
5 Therefore this study will investigate the greater effectiveness and safety of switching to the most potent combination versus maintaining LAMor LdT plus ADV and also compare the rate of VR based on the HBV DNA cut-off level at switching - more than and less than 20000 IUmL
All subjects will orally take assigned drugs once daily for 48 weeks All subjects will be assessed at baseline and every three months thereafter Evaluations at each visit will include vital signs physical examinations laboratory tests HBV DNA levels and adverse events At baseline and every six months thereafter serum will be assayed for HBV serology Genotypic analysis will be performed at baseline and 48 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None