Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03042481
Status:
UNKNOWN
Last Update Posted:
2017-02-03
First Post:
2017-01-23
Brief Title:
Off-therapy Response After Stopping Entecavir or Tenofovir
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
Comparison and Prediction of Off-therapy Response in Patients of Chronic Hepatitis B Treated With Entecavir or Tenofovir and Achieved Criteria of Stopping Therapy by APASL Guideline
Status:
UNKNOWN
Status Verified Date:
2017-01
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:
None
Brief Summary:
Pegylated-interferon Peg-IFN α-2a entecavir ETV and tenofovir disoproxil fumarate TDF are current recommended first-line antiviral therapies for chronic hepatitis B CHB Compared with Peg-IFN therapy nucleotside analogue NUC therapy has the advantages of having a potent antiviral effect and good tolerance without side effect The long-term safety and efficacy of ETV and TDF therapy had also been identified However poor durability of the effectiveness after stopping NUC therapy are encountered in the majority of patients Previous study identified a high HBV relapse rate of over 50 in HBeAg- positive CHB patients treated with lamivudine A recent study investigating the post-treatment durability of ETV showed that higher to 453 of the HBeAg-negative CHB patients happened a clinical relapse within 1-year after stopping ETV therapy TDF is another recommended first line NUC with high potency and high genetic barrier Although the efficacy of long-term TDF therapy had been identified there is lack of data regarding the off-therapy response in CHB patients with TDF therapy currently Only a small scale of patients treated with TDF were included in a recent study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after greater than 4 years of NUC therapy In addition the factors associated with off-therapy response are also still uncertain
The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver APASL criteria of stopping NUC therapy The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with ETV and TDF therapy and to identify the predictive factors of relapse
The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver APASL criteria of stopping NUC therapy The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with ETV and TDF therapy and to identify the predictive factors of relapse
Detailed Description:
None
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