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Report for Clinical Trial NCT00625560
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
Name: Entecavir
Description: entecavir 1.0 mg QD
Type: Drug
Name: Lamivudine
Description: lamivudine 100 mg QD
Type: Drug
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 ---