NCT00625560

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2008

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

February 11, 2008

Last Update Submit

May 7, 2012

Conditions

Hepatitis B, Chronic

Keywords

Chronic hepatitis BLamivudineEntecavir

Outcome Measures

Primary Outcomes (1)

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

    at Week 96

Secondary Outcomes (5)

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

    at Week 48

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

    at Week 48 and Week 96

  • Change from baseline in mean HBV DNA

    at Week 48 and 96

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

    at Week 48 and 96

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

    Follow up period

Study Arms (2)

A

EXPERIMENTAL

entecavir 1.0 mg QD

Drug: Entecavir

B

ACTIVE COMPARATOR

lamivudine 100 mg QD

Drug: Lamivudine

Interventions

EntecavirDRUG

entecavir 1.0 mg QD

Also known as: Baraclude 1.0mg
A
LamivudineDRUG

lamivudine 100 mg QD

Also known as: Zeffix 100mg
B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pusan National University School of Medicine

Busan, Busan, 602-739, South Korea

Location

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirLamivudine

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Sang Hoon Ahn, M.D.Ph.D

    Yonsei Univsersity College of Medicine

    STUDY CHAIR

  • Do Young Kim, M.D.

    Yonsei University

    STUDY DIRECTOR

  • Jun Yong Park, M.D

    Yonsei University

    PRINCIPAL INVESTIGATOR

  • Jeong Heo, M.D.Ph.D

    Pusan National University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 28, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2010

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

KR(2)