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Efficacy Optimizing Research of Lamivudine Therapy (EXPLORE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088009
First Posted: March 16, 2010
Last Update Posted: October 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Major Science and Technology Special Project of China Eleventh Five-year
GlaxoSmithKline
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
March 15, 2010
March 16, 2010
October 30, 2013
March 2010
February 2013   (Final data collection date for primary outcome measure)
the proportion of virological breakthrough with confirmed Lamivudine resistant mutants [ Time Frame: during 104 weeks study period ]
Same as current
Complete list of historical versions of study NCT01088009 on ClinicalTrials.gov Archive Site
  • proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL [ Time Frame: week 104 ]
  • Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104 [ Time Frame: baseline, week 104 ]
  • The proportion of subjects with ALT normalization at week 104 [ Time Frame: week 104 ]
  • The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week 104 ]
  • The proportion of subjects with HBsAg loss and seroconversion rates at week 104 [ Time Frame: week 104 ]
  • proportion of subjects with HBV DNA≤300 copies/mL [ Time Frame: week 104 ]
  • Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104 [ Time Frame: baseline, week 104 ]
  • The proportion of of subjects with ALT normalization at week 104 [ Time Frame: week 104 ]
  • The proportion of of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week 104 ]
  • The proportion of of subjects with HBsAg loss and seroconversion rates at week 104 [ Time Frame: week 104 ]
Not Provided
Not Provided
 
Efficacy Optimizing Research of Lamivudine Therapy
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Compensated Chronic Hepatitis B
  • Drug: lamivudine
    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
  • Drug: lamivudine
    Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
  • Drug: lamivudine, adefovir
    patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks
  • Experimental: early add-on
    Intervention: Drug: lamivudine
  • Active Comparator: SOC
    Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
    Intervention: Drug: lamivudine
  • De-novo combination
    patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks
    Intervention: Drug: lamivudine, adefovir
Xiang KH, Michailidis E, Ding H, Peng YQ, Su MZ, Li Y, Liu XE, Dao Thi VL, Wu XF, Schneider WM, Rice CM, Zhuang H, Li T. Effects of amino acid substitutions in hepatitis B virus surface protein on virion secretion, antigenicity, HBsAg and viral DNA. J Hepatol. 2017 Feb;66(2):288-296. doi: 10.1016/j.jhep.2016.09.005. Epub 2016 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
May 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01088009
MOH-02
Yes
Not Provided
Not Provided
Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
  • Major Science and Technology Special Project of China Eleventh Five-year
  • GlaxoSmithKline
Principal Investigator: JinLin Hou, MD Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP