Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B, Chronic
Intervention: Entecavir (Drug); Lamivudine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yonsei University Official(s) and/or principal investigator(s): Sang Hoon Ahn, M.D.Ph.D, Study Chair, Affiliation: Yonsei Univsersity College of Medicine Do Young Kim, M.D., Study Director, Affiliation: Yonsei University Jun Yong Park, M.D, Principal Investigator, Affiliation: Yonsei University Jeong Heo, M.D.Ph.D, Study Director, Affiliation: Pusan National University School of Medicine
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
Secondary outcome: Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapyPercentage number of patients who developed drug resistant mutations while on randomized therapy Change from baseline in mean HBV DNA Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment
Detailed description:
Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than
Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir
in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR)
may lead to full viral suppression to undetectable level by PCR method. The prompt switch
from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression
(HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study
will provide a rationale for switch treatment from one antiviral to another one, especially
from LAM to ETV.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for
chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg
positive at baseline.
Exclusion Criteria:
- All subjects will be tested for presence of M204V/I mutations in the YMDD motif at
baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not
eligible for the study.
- Subjects treated with other antiviral drugs (e. g. adefovir) in combination with
lamivudine are not eligible for this study.
- Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
- Subjects should be without serological evidence of co-infection with HCV, HIV, or
HDV.
- Subjects with decompensated liver disease, as well as pregnant or breast-feeding
women, will not be eligible for the study.
Locations and Contacts
Pusan National University School of Medicine, Busan 602-739, Korea, Republic of
Severance Hospital, Seoul 120-752, Korea, Republic of
Additional Information
Starting date: February 2008
Last updated: May 7, 2012
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