SNPMiner Trials (Home Page)
Report for Clinical Trial NCT01341743
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
The purpose of this study is to evaluate the efficacy and safety of generic entecavir
monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate
response to NUC therapy
Name: Entecavir
Description: patients will receive oral entecavir 1mg, daily for 104 weeks.
Type: Drug
Name: Entecavir, Adefovir
Description: patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Type: Drug
Name: Entecavir, Adefovir
Description: patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
Type: Drug
Primary Outcomes
Measure: proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 Time: week 104
Secondary Outcomes
Measure: serum HBV DNA reduction from baseline at week 104 Time: week 104
Measure: The proportion of subjects with ALT normalization at week 104 Time: week104
Measure: The proportion of subjects with HBeAg loss and seroconversion at week 104 Time: week104
Measure: The proportion of subject with HBsAg loss and seroconversion at week 104 Time: week104
Measure: The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 Time: week104
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 A181V
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104. --- A181V ---