SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation M204I

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 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
Conditions
  1. Hepatitis B, Chronic
Interventions
  1. Drug: telbivudine
  2. 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 ---

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 ---

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


HPO Nodes