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Report for Clinical Trial NCT03236610

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.

NCT03236610 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: tenofovir monotherapy

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

tenofovir

Name: tenofovir plus entecavir combination

Description: continuing tenofovir plus entecavir
Type: Drug
Group Labels: 1

tenofovir plus entecavir


Primary Outcomes

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

Measure: SVR at week 48

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) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months 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) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months 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) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months 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) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months 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 ---



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