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Report for Clinical Trial NCT00625560

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.

NCT00625560 Hepatitis B, Chronic
MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis
HPO:Hepatitis

2 Interventions

Name: Entecavir

Description: entecavir 1.0 mg QD
Type: Drug
Group Labels: 1

A

Name: Lamivudine

Description: lamivudine 100 mg QD
Type: Drug
Group Labels: 1

B


Primary Outcomes

Measure: Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy

Time: at Week 96

Secondary Outcomes

Measure: Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy

Time: at Week 48

Measure: Percentage number of patients who developed drug resistant mutations while on randomized therapy

Time: at Week 48 and Week 96

Measure: Change from baseline in mean HBV DNA

Time: at Week 48 and 96

Measure: Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion

Time: at Week 48 and 96

Measure: Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment

Time: Follow up period

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M204V

Exclusion Criteria: - All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. --- M204V ---

Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study. --- M204V ---



HPO Nodes


HPO: