Skip to main content
OpenTrials
Completed

NCT Number: NCT01088009

Efficacy Optimizing Research of Lamivudine Therapy

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Compensated 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 4

Primary location

BeiJing YouAn Hospital ,Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female aged 18-65 years;
  • Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
  • Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;

Exclusion criteria

  • History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
  • other protocol defined inclusion/exclusion criteria

Treatment and study plan

Lamivudine

Drug

patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104

lamivudine, adefovir

Drug

patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks

Primary outcomes

  1. the proportion of virological breakthrough with confirmed Lamivudine resistant mutants

    Time frame: during 104 weeks study period

Secondary outcomes

  1. proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL

    Time frame: week 104

  2. Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104

    Time frame: baseline, week 104

  3. The proportion of subjects with ALT normalization at week 104

    Time frame: week 104

  4. The proportion of subjects with HBeAg loss and seroconversion at week 104

    Time frame: week 104

  5. The proportion of subjects with HBsAg loss and seroconversion rates at week 104

    Time frame: week 104

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • GlaxoSmithKline
  • Major Science and Technology Special Project of China Eleventh Five-year

Registry information

Official study title

A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients

Acronym: EXPLORE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 16, 2010
Registry last updated
Oct 30, 2013

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.