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Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316719
First received: April 19, 2006
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of HBV DNA Loss (< 400 Copies/mL) [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of HBeAg Loss [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of HBeAg/Ab Seroconversion [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Mean Alanine Aminotransferase (ALT) Level at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of ALT Normalization [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Rate of Emergence of Resistant Virus at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316719

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov 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
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
treatment naive
CHB
adefovir
monotherapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Adefovir dipivoxil
Lamivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 21, 2013