Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00316719

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Adefovir Lamivudine Adefovir dipivoxil

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
Adefovir Dipivoxil (ADV): Experimental	Drug: ADV group Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
Lamivudine (LAM): Active Comparator	Drug: LAM group Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.

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:	GSK ( Study Director )
Study ID Numbers:	ADF105220
Study First Received:	April 19, 2006
Results First Received:	June 15, 2009
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00316719 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

treatment naive
CHB
adefovir
monotherapy

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Hepatitis, Viral, Human
Lamivudine
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Reverse Transcriptase Inhibitors

Hepatitis
Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010