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Report for Clinical Trial NCT01341743

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multi-center, Randomized, Controlled Study 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

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

NCT01341743 Hepatitis B
MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic
HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

3 Interventions

Name: Entecavir

Description: patients will receive oral entecavir 1mg, daily for 104 weeks.
Type: Drug
Group Labels: 1

A

Name: Entecavir, Adefovir

Description: patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Type: Drug
Group Labels: 1

B

Name: Entecavir, Adefovir

Description: patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
Type: Drug
Group Labels: 1

C


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: