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EFFORT Extension Study (EFFORT-Ex)

Primary Purpose

Hepatitis B, Chronic

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
telbivudine (ROADMAP)
Telbivudine (Standard of Care)
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Treated with telbivudine or combined with adefovir in EFFORT study
  • Patients are willing to participate in the extension study
  • Patients provide information consent form

Exclusion Criteria:

  • Adjustment of poor compliance by investigators

Sites / Locations

  • 302 Military Hospital Of China
  • 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
  • Department of Infectious Disease, Nanfang Hospital
  • No. 8 People's Hospital In GuangZhou
  • The Third Hospital of Sun Yat-Sen University
  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Xiangya Hospital Central-South Univrsity
  • No.81 Hospital of PLA
  • 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
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • The Sixth People's Hospital of Hangzhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ROADMAP

SOC (Standard of Care)

Arm Description

Outcomes

Primary Outcome Measures

The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II

Secondary Outcome Measures

Percentage of patients achieving HBV DNA <300copies/mL at week 156
The log10 reduction in HBV DNA from baseline of EFFORT study at week 156
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156
Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156
The percentage of patients with ALT normalization at week 156
Percentage of patients with HBV DNA breakthrough at week 156
Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156
sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration
percentage of hepatitis flare at week 52 of off-treatment duration

Full Information

First Posted
September 20, 2011
Last Updated
June 17, 2014
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01529255
Brief Title
EFFORT Extension Study
Acronym
EFFORT-Ex
Official Title
A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

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, Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy. To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Chronic Hepatitis B, Compensated 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
576 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ROADMAP
Arm Type
Experimental
Arm Title
SOC (Standard of Care)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
telbivudine (ROADMAP)
Intervention Description
Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.
Intervention Type
Drug
Intervention Name(s)
Telbivudine (Standard of Care)
Intervention Description
Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial.
Primary Outcome Measure Information:
Title
The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of patients achieving HBV DNA <300copies/mL at week 156
Time Frame
Week 156
Title
The log10 reduction in HBV DNA from baseline of EFFORT study at week 156
Time Frame
Week 156
Title
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156
Time Frame
Week 156
Title
Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156
Time Frame
Week 156
Title
The percentage of patients with ALT normalization at week 156
Time Frame
Week 156
Title
Percentage of patients with HBV DNA breakthrough at week 156
Time Frame
Week 156
Title
Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156
Time Frame
Week 156
Title
sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration
Time Frame
week 52 of off-treatment
Title
percentage of hepatitis flare at week 52 of off-treatment duration
Time Frame
week 52 of off-treatment

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: Treated with telbivudine or combined with adefovir in EFFORT study Patients are willing to participate in the extension study Patients provide information consent form Exclusion Criteria: Adjustment of poor compliance by investigators
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
302 Military Hospital Of China
City
Beijing
State/Province
Beijing
Country
China
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
Department of Infectious Disease, Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
No. 8 People's Hospital In GuangZhou
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Third Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
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
No.81 Hospital of PLA
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
First Hospital .Jilin Unniversity
City
Changchun
State/Province
Jilin
Country
China
Facility Name
ShengJing Hospital of China Medical University
City
Shengyang
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
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Sixth People's Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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EFFORT Extension Study

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