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Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00316719
First Posted: April 21, 2006
Last Update Posted: October 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
  Purpose
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: Quadruple (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316719


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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00316719     History of Changes
Other Study ID Numbers: ADF105220
First Submitted: April 19, 2006
First Posted: April 21, 2006
Results First Submitted: June 15, 2009
Results First Posted: August 3, 2009
Last Update Posted: October 6, 2009
Last Verified: October 2009

Keywords provided by GlaxoSmithKline:
treatment naive
CHB
adefovir
monotherapy

Additional relevant MeSH terms:
Hepatitis
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
Lamivudine
Adefovir
Adefovir dipivoxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents