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Report for Clinical Trial NCT01341743
Developed by Shray Alag, 2020.
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 ---
HPO Nodes
HPO: Protein Mutations 0
SNP 0