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Efficacy Optimizing Research of Lamivudine Therapy (EXPLORE)

Primary Purpose

Compensated Chronic Hepatitis B

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
lamivudine
lamivudine
lamivudine, adefovir
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compensated Chronic Hepatitis B focused on measuring chronic hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Ditan Hospita
  • Beijing Friendship Hospital Attached to the Capital Medical University
  • BeiJing YouAn Hospital ,Capital Medical University
  • Department of infectious disease, First Hospital of Peking University
  • People'S Hospital Under Beijnig University
  • The Second Affiliated of ChongQing University of Medical Science
  • The First Affiliated Hospital of Fujian Medical University
  • The First People's Hospital of Foshan
  • Department of infectious disease, Nanfang Hospital
  • GuangDong Provincial People's hospital
  • First Affiliated Hospital of Guangxi Medical University
  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Xiangya Hospital Central-South Univrsity
  • First Hospital .Jilin Unniversity
  • ShengJing Hospital of China Medical University
  • JiNan Infectious Diseases Hospital
  • Changhai Hospital affiliated to Second Military Medical University
  • Huashan Hospital，Fudan University
  • No.85 Hospital of PLA
  • Shanghai Ruijin Hospital
  • Tangdu Hospital
  • West China Hospital.SiChuan University
  • HangZhou No.6 People Hospital
  • The First Affiliated Hospital of College of Medicine ，Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

early add-on

SOC

De-novo combination

Arm Description

Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily

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

Outcomes

Primary Outcome Measures

the proportion of virological breakthrough with confirmed Lamivudine resistant mutants

Secondary Outcome Measures

proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL
Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104
The proportion of subjects with ALT normalization at week 104
The proportion of subjects with HBeAg loss and seroconversion at week 104
The proportion of subjects with HBsAg loss and seroconversion rates at week 104

Full Information

First Posted
March 15, 2010
Last Updated
October 28, 2013
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01088009
Brief Title
Efficacy Optimizing Research of Lamivudine Therapy
Acronym
EXPLORE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compensated Chronic Hepatitis B
Keywords
chronic hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early add-on
Arm Type
Experimental
Arm Title
SOC
Arm Type
Active Comparator
Arm Description
Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
Arm Title
De-novo combination
Arm Type
Other
Arm Description
patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks
Intervention Type
Drug
Intervention Name(s)
lamivudine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
lamivudine
Intervention Description
Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
Intervention Type
Drug
Intervention Name(s)
lamivudine, adefovir
Intervention Description
patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks
Primary Outcome Measure Information:
Title
the proportion of virological breakthrough with confirmed Lamivudine resistant mutants
Time Frame
during 104 weeks study period
Secondary Outcome Measure Information:
Title
proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL
Time Frame
week 104
Title
Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104
Time Frame
baseline, week 104
Title
The proportion of subjects with ALT normalization at week 104
Time Frame
week 104
Title
The proportion of subjects with HBeAg loss and seroconversion at week 104
Time Frame
week 104
Title
The proportion of subjects with HBsAg loss and seroconversion rates at week 104
Time Frame
week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JinLin Hou, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospita
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital Attached to the Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
BeiJing YouAn Hospital ,Capital Medical University
City
BeiJing
State/Province
Beijing
Country
China
Facility Name
Department of infectious disease, First Hospital of Peking University
City
BeiJing
State/Province
Beijing
Country
China
Facility Name
People'S Hospital Under Beijnig University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Affiliated of ChongQing University of Medical Science
City
ChongQing
State/Province
Chongqing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
FuZhou
State/Province
Fujian
Country
China
Facility Name
The First People's Hospital of Foshan
City
FoShan
State/Province
Guangdong
Country
China
Facility Name
Department of infectious disease, Nanfang Hospital
City
GuangZhou
State/Province
Guangdong
Country
China
Facility Name
GuangDong Provincial People's hospital
City
GuangZhou
State/Province
Guangdong
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
NanNing
State/Province
Guangxi
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital Central-South Univrsity
City
ChangSha
State/Province
Hunan
Country
China
Facility Name
First Hospital .Jilin Unniversity
City
ChangChun
State/Province
Jilin
Country
China
Facility Name
ShengJing Hospital of China Medical University
City
ShenYang
State/Province
Liaoning
Country
China
Facility Name
JiNan Infectious Diseases Hospital
City
JINan
State/Province
Shandong
Country
China
Facility Name
Changhai Hospital affiliated to Second Military Medical University
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
Huashan Hospital，Fudan University
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
No.85 Hospital of PLA
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital
City
XiAn
State/Province
Shanxi
Country
China
Facility Name
West China Hospital.SiChuan University
City
ChengDu
State/Province
Sichuan
Country
China
Facility Name
HangZhou No.6 People Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine ，Zhejiang University
City
HangZhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27650283
Citation
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.
Results Reference
derived

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Efficacy Optimizing Research of Lamivudine Therapy

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