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A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00857675
First received: March 5, 2009
Last updated: April 2, 2009
Last verified: April 2009
History of Changes
  Purpose

The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.


Condition Intervention Phase
Chronic Hepatitis B
 Drug: AAAA
Drug: AAPA
Drug: PAAA
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Double-Blind , Randomized, Placebo-Controlled Phase II/III Study of Adefovir Dipivoxil for the Treatment of Chinese Patients With HBeAg Positive Chronic Hepatitis B Followed by Long-Term (5 Years Total) Adefovir Dipivoxil Treatment. (Report on Year 1 and Year 2 Data)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects with ALT normalisation [ Time Frame: Week 52, 104, 156, 208, 260 ]
  • log10 reduction in serum HBV DNA [ Time Frame: Week 52, 104, 156, 208, 260 ]
  • The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level [ Time Frame: Week 52, 104, 156, 208, 260 ]
  • The proportion of subjects with HBeAg loss [ Time Frame: Week 52, 104, 156, 208, 260 ]
  • The proportion of subjects with HBeAg seroconversion [ Time Frame: Week 52, 104, 156, 208, 260 ]
  • The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance [ Time Frame: Week 52, 104, 156, 208, 260 ]
  • The proportion of subjects with HBV DNA undetectable (<300 copies/mL) [ Time Frame: Week 52, 104, 156, 208, 260 ]

Enrollment: 480
Study Start Date: December 2002
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adefovir Dipivoxil
ADV 10mg tablets once daily
 Drug: AAAA
Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)
Drug: AAPA
Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
Drug: PAAA
Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)
Placebo Comparator: Adefovir Dipivoxil matched placebo
Adefovir Dipivoxil matched placebo one tablet once daily
 Drug: AAPA
Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
Drug: PAAA
Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-65 years
  • Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
  • Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).
  • Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.

Exclusion Criteria:

  • Evidence of hepatocellular carcinoma;
  • Clinical signs of liver decompensation;
  • Serum creatinine more than 1.5 mg/dL;
  • ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;
  • Lamivudine therapy within 3 months prior to screening;
  • ADV therapy or any other anti-HBV therapy within the previous 6 months;
  • Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857675

Locations
China, Guangdong
GSK Investigational Site
Guangzhou, Guangdong, China, 510515
GSK Investigational Site
Guangzhou, Guangdong, China, 510630
China, Jilin
GSK Investigational Site
Changchun, Jilin, China, 130021
China, Shandong
GSK Investigational Site
Jinan, Shandong, China
China, Zhejiang
GSK Investigational Site
Hangzhou, Zhejiang, China, 310003
China
GSK Investigational Site
Beijing, China, 100044
GSK Investigational Site
Beijing, China, 100011
GSK Investigational Site
Chongqing, China, 400038
GSK Investigational Site
Chongquin, China, 400038
GSK Investigational Site
Shanghai, China, 200040
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00857675     History of Changes
Other Study ID Numbers: ADF30001
Study First Received: March 5, 2009
Last Updated: April 2, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HBV DNA suppression
ALT normalisation
Viral resistance
HBeAg seroconversion

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
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

ClinicalTrials.gov processed this record on May 19, 2013