NCT00823550

Brief Summary

This is a randomized, open label, phase IV, multicenter study for efficacy and safety of lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high viral load and normal or slightly elevated transaminase.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
462

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 16, 2010

Status Verified

January 1, 2009

Enrollment Period

5.5 years

First QC Date

January 14, 2009

Last Update Submit

December 15, 2010

Conditions

Hepatitis B, Chronic

Keywords

Chronic hepatitis BAdvanced fibrosisLamivudineEntecavir

Outcome Measures

Primary Outcomes (1)

  • Time to disease progression as defined by the first occurrence of any of the cirrhosis compolications

    5 years

Secondary Outcomes (1)

  • Proportion of patients achieving either HBV DNA level ≤ 60 IU/mL Proportion of patients with ALT normalization Proportion of patients with HBeAg loss and seronconversion Proportion of patients with virologic breakthrough

    at months 12, 24, 36, 48, and 60

Study Arms (2)

A

EXPERIMENTAL

entecavir 0.5 mg QD

Drug: Entecavir

B

ACTIVE COMPARATOR

lamivudine 100 mg QD

Drug: Lamivudine

Interventions

EntecavirDRUG

entecavir 0.5 mg QD

Also known as: Baraclude 0.5mg
A
LamivudineDRUG

lamivudine 100 mg QD

Also known as: Zeffix 100mg
B

Eligibility Criteria

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

You may qualify if:

  • Male and female, 18 years of age or older
  • HBsAg positive for more than 6 months
  • Serum HBV DNA \> 2,000 IU/ml
  • Serum ALT \< 2 X ULN on two consecutive occasions at least 3 months apart
  • Naïve to nucleoside or nucleotide therapy
  • On liver biopsy, fibrosis score ≥ 3 according to METAVIR scoring system (within 2 years of Day 0)
  • If liver biopsy is not available, subjects must have two of the following items
  • Overt findings of cirrhosis by radiologic evidence (MRI, CT, US)
  • Gastrointestinal varices
  • Platelet count \< 100,000,Splenomegaly (Spleen size - 12cm)
  • The patient who is willing and able to provide written informed consent to participate in this study

You may not qualify if:

  • A history of SBP, variceal bleeding, HEP, HCC
  • Decompensated liver disease (Child-Pugh score \> 10)
  • Co-infected with HCV or HIV
  • History of any other forms of liver disease.
  • Patient who is pregnant or breastfeeding
  • Treatment with immunosuppressive, immunomodulatory agents or antiviral agents within 6 months prior to study entry
  • A history of liver transplantation or planned for liver transplantation
  • A history of any other medical disease or condition that would make the patients unsuitable for the study.
  • Patient is currently abusing alcohol or illicit drugs or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years.
  • Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 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

  • Kwnag-Hyub Han, MD

    Yonsei Univsersity College of Medicine

    STUDY CHAIR

  • Jun Yong Park, MD

    Yonsei Univsersity College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

December 16, 2010

Record last verified: 2009-01

Locations

KR(1)