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Report for Clinical Trial NCT03236584

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial

Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy

NCT03236584 Proportion of Patients With a Sustained Virological Response (Serum HBV DNA Proportion of Patients With a Sustained Virological Response (Serum HBV DNA < Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
MeSH:Hepatitis B Hepatitis B, Chronic

2 Interventions

Name: lamivudine plus adefovir combination

Description: continuing lamivudine plus adefovir
Type: Drug
Group Labels: 1

lamivudine adefovir

Name: Tenofovir Disoproxil Fumarate

Description: switching to tenofovir
Type: Drug
Group Labels: 1

tenofovir


Primary Outcomes

Description: Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48

Measure: SVR

Time: 48 WEEK

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M204V

Inclusion Criteria: - HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval Exclusion Criteria: - Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV Inclusion Criteria: - HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval Exclusion Criteria: - Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV Proportion of Patients With a Sustained Virological Response (Serum HBV DNA Proportion of Patients With a Sustained Virological Response (Serum HBV DNA < Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 Hepatitis B Hepatitis B, Chronic null --- M204V ---

Inclusion Criteria: - HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval Exclusion Criteria: - Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV Inclusion Criteria: - HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval Exclusion Criteria: - Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV Proportion of Patients With a Sustained Virological Response (Serum HBV DNA Proportion of Patients With a Sustained Virological Response (Serum HBV DNA < Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 Hepatitis B Hepatitis B, Chronic null --- M204V --- --- M204V ---



HPO Nodes