Efficacy Optimizing Research of Lamivudine Therapy (EXPLORE)

This study has been completed.
Sponsor:
Collaborators:
Major Science and Technology Special Project of China Eleventh Five-year
GlaxoSmithKline
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01088009
First received: March 15, 2010
Last updated: October 28, 2013
Last verified: September 2013

March 15, 2010
October 28, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104 [ Time Frame: baseline, week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBsAg loss and seroconversion rates at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • proportion of subjects with HBV DNA≤300 copies/mL [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104 [ Time Frame: baseline, week 104 ] [ Designated as safety issue: No ]
  • The proportion of of subjects with ALT normalization at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of of subjects with HBsAg loss and seroconversion rates at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01088009
MOH-02
Yes
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