Efficacy Optimizing Research of Lamivudine Therapy (EXPLORE)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

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

GlaxoSmithKline

Information provided by:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT01088009

First received: March 15, 2010

Last updated: March 2, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2010

Last Updated Date

March 2, 2012

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the proportion of virological breakthrough with confirmed Lamivudine resistant mutants [ Time Frame: during 104 weeks study period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01088009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy Optimizing Research of Lamivudine Therapy

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Compensated Chronic Hepatitis B

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

360

Estimated Completion Date

May 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01088009

Other Study ID Numbers ^ICMJE

MOH-02

Has Data Monitoring Committee

Yes

Responsible Party

Jinlin Hou, Nanfang hospital

Study Sponsor ^ICMJE

Nanfang Hospital of Southern Medical University

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

JinLin Hou, MD

Nanfang Hospital,Southern Medical University

Information Provided By

Nanfang Hospital of Southern Medical University

Verification Date

March 2012

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

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