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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

A

Name: Entecavir, Adefovir

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

Type: Drug

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

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:
Chronic active hepatitis
Genes 5
ALMS1 KRT8 AIRE C4B KRT18
Chronic hepatitis
Genes 11
ALMS1 KRT8 IL21R AIRE RFXAP C4B RFXANK CD40LG KRT18 RFX5 CIITA
Hepatitis
Genes 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3