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Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: April 19, 2006
Last updated: October 1, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Chronic Hepatitis B
Drug: LAM group
Drug: ADV group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52 [ Time Frame: Baseline and Week 52 ]

Secondary Outcome Measures:
  • Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52 [ Time Frame: Week 52 ]
  • Time to Onset of HBV DNA Loss (< 400 Copies/mL) [ Time Frame: From Baseline to Week 52 ]
  • Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52 [ Time Frame: Week 52 ]
  • Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ]
  • Time to Onset of HBeAg Loss [ Time Frame: From Baseline to Week 52 ]
  • Time to Onset of HBeAg/Ab Seroconversion [ Time Frame: From Baseline to Week 52 ]
  • Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52 [ Time Frame: Week 52 ]
  • Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ]
  • Mean Alanine Aminotransferase (ALT) Level at Week 52 [ Time Frame: Week 52 ]
  • Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52 [ Time Frame: Week 52 ]
  • Time to Onset of ALT Normalization [ Time Frame: From Baseline to Week 52 ]
  • Rate of Emergence of Resistant Virus at Week 52 [ Time Frame: Week 52 ]

Enrollment: 105
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adefovir Dipivoxil (ADV) Drug: ADV group
Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
Other Name: adefovir dipivoxil
Active Comparator: Lamivudine (LAM) Drug: LAM group
Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
Other Name: Lamivudine


Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00316719

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00316719     History of Changes
Other Study ID Numbers: ADF105220
Study First Received: April 19, 2006
Results First Received: June 15, 2009
Last Updated: October 1, 2009

Keywords provided by GlaxoSmithKline:
treatment naive

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents processed this record on April 28, 2017