EFFORT Extension Study (EFFORT-Ex)
This study is currently recruiting participants.
Verified April 2013 by Nanfang Hospital of Southern Medical University
Sponsor:
Nanfang Hospital of Southern Medical University
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
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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,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 May 21, 2013