SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00962533

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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
MeSH: Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic
HPO: Hepatitis

2 Interventions

Name: telbivudine

Description: telbivudine, 600mg, oral, daily

Type: Drug

ROADMAP Group (Group I)

Name: telbivudine

Description: telbivudine, 600mg, oral, daily

Type: Drug

SOC (Standard of Care) Group (Group II)


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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 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 Hepatitis A Hepatitis B Hepatitis B, Chronic 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 Hepatitis A Hepatitis B Hepatitis B, Chronic null --- M204I --- --- N236T --- --- A181V --- --- M204I --- --- N236T --- --- A181V ---


2 M204I

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 Hepatitis A Hepatitis B Hepatitis B, Chronic null --- M204I ---

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 Hepatitis A Hepatitis B Hepatitis B, Chronic null --- M204I --- --- N236T --- --- A181V --- --- M204I ---


3 N236T

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 Hepatitis A Hepatitis B Hepatitis B, Chronic null --- M204I --- --- N236T ---

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 Hepatitis A Hepatitis B Hepatitis B, Chronic null --- M204I --- --- N236T --- --- A181V --- --- M204I --- --- N236T ---



HPO Nodes


HPO:
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