SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01341743

Developed by Shray Alag, 2019.
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 Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, 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
KRT8 ALMS1 C4B KRT18 AIRE
Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG
Hepatitis
Genes 74
TTC7A MST1 TRAF3IP2 TPP2 TBX19 IL12A MET IL12RB1 RASGRP1 TCF4 HSD3B7 KRT8 SERPINA1 TCF3 VIPAS39 ATP7A IGF2R MMEL1 ATP7B ALMS1 SPIB KRT18 VPS33B CIITA PDGFRL PIK3CA GPR35 CYP7A1 GUSB PIK3R1 AMACR RFXANK SHPK IGHM PIEZO1 SLC25A15 BTK IL21R CD40LG BLNK GLIS3 APC CLEC7A AIRE LRRC8A CASP8 POU2AF1 XIAP CASP10 C1S CYP7B1 PRKCD CD79A CD79B IRF5 C4B IL17RC IL17RA IGLL1 CTNNB1 FAS SKIV2L FASLG SH2D1A RFX5 IL17F RFXAP TNFSF15 TNPO3 PGM1 STAT1 TP53 AXIN1 FOXP3