Clinical trial NCT00637663: Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA
Official title: Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Chronic hepatitis B
Lamivudine
Entecavir
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: Yonsei University
First posted: 2008-03-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Detailed description: Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA \< 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Eligibility 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 status.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
timeFrame: at Week 96
Secondary outcomes:
measure: Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
timeFrame: at Week 48
measure: Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion
timeFrame: at Week 48 and 96
measure: Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough, Safety assessment
timeFrame: Follow up period
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Pusan National University
name: Jeong Heo, M.D. Ph.D
role: STUDY_CHAIR
affiliation: Yonsei Univsersity College of Medicine
name: Sang Hoon Ahn, M.D.Ph.D
role: STUDY_DIRECTOR
affiliation: Yonsei University
name: Jun Yong Park, M.D
role: PRINCIPAL_INVESTIGATOR
References: