Skip to main content
OpenTrials
Completed

NCT Number: NCT00857675

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AAAA

Drug

Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)

AAPA

Drug

Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)

PAAA

Drug

Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)

Primary outcomes

  1. The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo

    Time frame: Week 12

Secondary outcomes

  1. The proportion of subjects with ALT normalisation

    Time frame: Week 52, 104, 156, 208, 260

  2. log10 reduction in serum HBV DNA

    Time frame: Week 52, 104, 156, 208, 260

  3. 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

  4. The proportion of subjects with HBeAg loss

    Time frame: Week 52, 104, 156, 208, 260

  5. The proportion of subjects with HBeAg seroconversion

    Time frame: Week 52, 104, 156, 208, 260

  6. The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance

    Time frame: Week 52, 104, 156, 208, 260

  7. The proportion of subjects with HBV DNA undetectable (<300 copies/mL)

    Time frame: Week 52, 104, 156, 208, 260

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Mar 9, 2009
Registry last updated
Apr 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.