EFFORT Extension Study (EFFORT-Ex)

This study is currently recruiting participants.
Verified April 2013 by Nanfang Hospital of Southern Medical University
Sponsor:
Collaborators:
Major Science and Technology Special Project of China Eleventh Five-year
Novartis
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01529255
First received: September 20, 2011
Last updated: April 21, 2013
Last verified: April 2013
  Purpose
  • 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

Condition Intervention Phase
Hepatitis B, Chronic
Drug: telbivudine (ROADMAP)
Drug: Telbivudine (Standard of Care)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving HBV DNA <300copies/mL at week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • The log10 reduction in HBV DNA from baseline of EFFORT study at week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • The percentage of patients with ALT normalization at week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBV DNA breakthrough at week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156 [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration [ Time Frame: week 52 of off-treatment ] [ Designated as safety issue: No ]
  • percentage of hepatitis flare at week 52 of off-treatment duration [ Time Frame: week 52 of off-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 576
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ROADMAP Drug: telbivudine (ROADMAP)

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.

Active Comparator: SOC (Standard of Care) Drug: Telbivudine (Standard of Care)

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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529255

Contacts
Contact: Jinlin Hou, MD 86-20-61641941 jlhousmu@yahoo.com.cn
Contact: Jian Sun 86-20-62787432 sunjian@fimmu.com

Locations
China, Beijing
Department of Infectious Disease, First Hospital of Peking University Recruiting
Beijing, Beijing, China
Contact: Yanyan Yu    13901194223      
Principal Investigator: Yanyan Yu, MD         
Beijing Friendship Hospital Attached To The Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Hong Ma    13651096128      
Principal Investigator: Hong Ma         
Beijing Ditan Hospita Recruiting
Beijing, Beijing, China
Contact: Jun Cheng    13701223262      
Principal Investigator: Jun Cheng         
People's Hospital Under Beijnig University Recruiting
Beijing, Beijing, China
Contact: Hao Wang    13801051583      
Principal Investigator: Hao Wang         
302 Military Hospital Of China Recruiting
Beijing, Beijing, China
Contact: Hongfei Zhang    13311178668      
Principal Investigator: Hongfei Zhang         
BeiJing YouAn Hospital ,Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Xinyue Chen    13911212398      
Principal Investigator: Xinyue Chen         
China, Chongqing
The Second Affiliated of ChongQing University of Medical Science Recruiting
Chongqing, Chongqing, China
Contact: Hong Ren    13983888786      
Principal Investigator: Hong Ren         
China, Guangdong
Department of Infectious Disease, Nanfang Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Jinlin Hou, MD    86-20-61641941      
Principal Investigator: Jinlin Hou, MD         
Sub-Investigator: Jian Sun, MD         
The Third Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China
Contact: Zhiliang Gao    13902263533      
Principal Investigator: Zhiliang Gao         
No. 8 People's Hospital In GuangZhou Recruiting
Guangzhou, Guangdong, China
Contact: Min Xu    13802969935      
Principal Investigator: Min Xu         
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Qin Ning    13971521450      
Principal Investigator: Qin Ning         
China, Hunan
Xiangya Hospital Central-South Univrsity Recruiting
Changsha, Hunan, China
Contact: Deming Tan    13975886582      
Principal Investigator: Deming Tan         
China, Jiangsu
No.81 Hospital of PLA Recruiting
Nanjing, Jiangsu, China
Contact: Maorong Wang    13401935666      
Principal Investigator: Maorong Wang         
China, Jilin
First Hospital .Jilin Unniversity Recruiting
Changchun, Jilin, China
Contact: Junqi Niu    13756661205      
Principal Investigator: Junqi Niu         
China, Liaoning
ShengJing Hospital of China Medical University Recruiting
Shengyang, Liaoning, China
Contact: Xiaoguang Dou    13898867074      
Principal Investigator: Xiaoguang Dou         
China, Shandong
JiNan Infectious Diseases Hospital Recruiting
Jinan, Shandong, China
Contact: Shijun Chen    13335153216      
Principal Investigator: Shijun Chen         
China, Shanghai
Huashan Hospital,Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Guangfeng Shi    13817780666      
Principal Investigator: Guangfeng Shi         
Changhai Hospital affiliated to Second Military Medical University Recruiting
Shanghai, Shanghai, China
Contact: Mobin Wan    13801678857      
Principal Investigator: Mobin Wan         
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China
Contact: Qing Xie    13651804273      
Principal Investigator: Qing Xie         
No.85 Hospital of PLA Recruiting
Shanghai, Shanghai, China
Contact: Chengwei Chen    13401935666      
Principal Investigator: Chengwei Chen         
China, Shanxi
Tangdu Hospital Recruiting
Xian, Shanxi, China
Contact: Xuefan Bai    13572229209      
Principal Investigator: Xuefan Bai         
China, Sichuan
West China Hospital.SiChuan University Recruiting
Chengdu, Sichuan, China
Contact: Hong Tang    13550097722      
Principal Investigator: Hong Tang         
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Jifang Sheng    13600519200      
Principal Investigator: Jifang Sheng         
The Sixth People's Hospital of Hangzhou Recruiting
Hangzhou, Zhejiang, China
Contact: Guoqiang Lou    13605700955      
Principal Investigator: Guoqiang Lou         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China Eleventh Five-year
Novartis
Investigators
Principal Investigator: Jinlin Hou, MD Nanfang Hospital of Southern Medical University
  More Information

No publications provided

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01529255     History of Changes
Other Study ID Numbers: MOH-05
Study First Received: September 20, 2011
Last Updated: April 21, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
Chronic Hepatitis B
Compensated Chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on April 15, 2014