SNPMiner Trials (Home Page)
Report for Mutation A181V
 Developed by Shray Alag, 2020.
SNP Clinical Trial Gene 
There are 3 clinical trials
Clinical Trials
      The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in
      treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
    
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance. --- N236T ---  --- A181V --- 
  Primary Outcomes 
 Measure: The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
 Time: Week 12
  Secondary Outcomes 
 Measure: The proportion of subjects with ALT normalisation
 Time: Week 52, 104, 156, 208, 260
 Measure: log10 reduction in serum HBV DNA
 Time: Week 52, 104, 156, 208, 260
 Measure: The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level
 Time: Week 52, 104, 156, 208, 260
 Measure: The proportion of subjects with HBeAg loss
 Time: Week 52, 104, 156, 208, 260
 Measure: The proportion of subjects with HBeAg seroconversion
 Time: Week 52, 104, 156, 208, 260
 Measure: The proportion of subjects developing N236T and 
A181V HBV DNA genotypic mutations associated with ADV resistance
 Time: Week 52, 104, 156, 208, 260
 Measure: The proportion of subjects with HBV DNA undetectable (<300 copies/mL)
 Time: Week 52, 104, 156, 208, 260
2 A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study) 
      The purpose of this trial is to prove that the strategy of treatment adjustment at W24
      according to virological response based on ROADMAP concept is better than standard of care
      strategy.
    
NCT00962533  Hepatitis B, Chronic  Drug: telbivudine  Drug: telbivudine MeSH: Hepatitis A    Hepatitis B    Hepatitis B, Chronic    Hepatitis   
HPO: Hepatitis   
Inclusion Criteria:
          -  Male or female, from 18 (inclusive) to 65 (inclusive) years of age
          -  HBsAg and HBeAg positive for over six months
          -  Patient is willing and able to comply with the study drug regimen and all other study
             requirements
          -  Patients must give written informed consent before any assessment is performed
        Exclusion Criteria:
          -  Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
          -  Patient has a history of or clinical signs/symptoms of hepatic decompensation
          -  Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of
             possible HCC
          -  Other protocol-defined inclusion/exclusion criteria may apply
      
        Inclusion Criteria:
          -  Male or female, from 18 (inclusive) to 65 (inclusive) years of age
          -  HBsAg and HBeAg positive for over six months
          -  Patient is willing and able to comply with the study drug regimen and all other study
             requirements
          -  Patients must give written informed consent before any assessment is performed
        Exclusion Criteria:
          -  Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
          -  Patient has a history of or clinical signs/symptoms of hepatic decompensation
          -  Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of
             possible HCC
          -  Other protocol-defined inclusion/exclusion criteria may apply
      
Hepatitis B, Chronic
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
null --- M204I ---  --- N236T ---  --- A181V --- 
Inclusion Criteria:
          -  Male or female, from 18 (inclusive) to 65 (inclusive) years of age
          -  HBsAg and HBeAg positive for over six months
          -  Patient is willing and able to comply with the study drug regimen and all other study
             requirements
          -  Patients must give written informed consent before any assessment is performed
        Exclusion Criteria:
          -  Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
          -  Patient has a history of or clinical signs/symptoms of hepatic decompensation
          -  Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of
             possible HCC
          -  Other protocol-defined inclusion/exclusion criteria may apply
      
        Inclusion Criteria:
          -  Male or female, from 18 (inclusive) to 65 (inclusive) years of age
          -  HBsAg and HBeAg positive for over six months
          -  Patient is willing and able to comply with the study drug regimen and all other study
             requirements
          -  Patients must give written informed consent before any assessment is performed
        Exclusion Criteria:
          -  Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
          -  Patient has a history of or clinical signs/symptoms of hepatic decompensation
          -  Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of
             possible HCC
          -  Other protocol-defined inclusion/exclusion criteria may apply
      
Hepatitis B, Chronic
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
null --- M204I ---  --- N236T ---  --- A181V ---  --- M204I ---  --- N236T ---  --- A181V --- 
  Primary Outcomes 
 Measure: To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II
 Time: Week 104
  Secondary Outcomes 
 Measure: Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
 Time: week 52
 Measure: Serum HBV DNA reduction from baseline at week 104
 Time: week 104
 Measure: Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
 Time: week 104
 Measure: Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline
 Time: week 104
 Measure: Serum HBV DNA reduction from baseline at week 52
 Time: week 52
3 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  Drug: Entecavir  Drug: Entecavir, Adefovir  Drug: Entecavir, Adefovir MeSH: Hepatitis A    Hepatitis B    Hepatitis B, Chronic    Hepatitis    Hepatitis, Chronic   
HPO: Chronic active hepatitis    Chronic hepatitis    Hepatitis   
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104. --- A181V --- 
  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
HPO Nodes
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   hr>
Chronic hepatitis 
Genes 11
ALMS1  KRT8  IL21R  AIRE  RFXAP  C4B  RFXANK  CD40LG  KRT18  RFX5  CIITA   hr>