NCT00316719

Brief Summary

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 3, 2009

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

April 19, 2006

Results QC Date

June 15, 2009

Last Update Submit

October 1, 2009

Conditions

Chronic Hepatitis B

Keywords

treatment naiveCHBadefovirmonotherapy

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52

    Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52

    Baseline and Week 52

Secondary Outcomes (12)

  • Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52

    Week 52

  • Time to Onset of HBV DNA Loss (< 400 Copies/mL)

    From Baseline to Week 52

  • Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52

    Week 52

  • Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52

    Week 52

  • Time to Onset of HBeAg Loss

    From Baseline to Week 52

  • +7 more secondary outcomes

Study Arms (2)

Adefovir Dipivoxil (ADV)

EXPERIMENTAL
Drug: ADV group

Lamivudine (LAM)

ACTIVE COMPARATOR
Drug: LAM group

Interventions

LAM groupDRUG

Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.

Also known as: Lamivudine
Lamivudine (LAM)
ADV groupDRUG

Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.

Also known as: adefovir dipivoxil
Adefovir Dipivoxil (ADV)

Eligibility Criteria

Age16 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Have compensated chronic hepatitis B.
  • Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
  • Ability to read, understand, and sign the informed consent.
  • Have a positive serum HBV-DNA \>= 1,000,000 copies/mL and ALT level 50-500 U/L

You may not qualify if:

  • Having or suspected of having liver cancer.
  • Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
  • Autoimmune hepatitis.
  • Received any previous transplantation or having a plan for any transplantation.
  • Existence of any serious complication, except hepatitis B.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Lamivudineadefovir dipivoxil

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

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 19, 2006

First Posted

April 21, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 6, 2009

Results First Posted

August 3, 2009

Record last verified: 2009-10