EFFORT Extension Study

Hepatitis B, Chronic Clinical Trial

— EFFORT-Ex  

Official title:

A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01529255
• Other study ID #: MOH-05
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 20, 2011
• Last updated: June 17, 2014
• Start date: August 2011
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 576
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	302 Military Hospital Of China	Beijing	Beijing
China	Beijing Ditan Hospita	Beijing	Beijing
China	Beijing Friendship Hospital Attached To The Capital Medical University	Beijing	Beijing
China	BeiJing YouAn Hospital ,Capital Medical University	Beijing	Beijing
China	Department of Infectious Disease, First Hospital of Peking University	Beijing	Beijing
China	People's Hospital Under Beijnig University	Beijing	Beijing
China	First Hospital .Jilin Unniversity	Changchun	Jilin
China	Xiangya Hospital Central-South Univrsity	Changsha	Hunan
China	West China Hospital.SiChuan University	Chengdu	Sichuan
China	The Second Affiliated of ChongQing University of Medical Science	Chongqing	Chongqing
China	Department of Infectious Disease, Nanfang Hospital	Guangzhou	Guangdong
China	No. 8 People's Hospital In GuangZhou	Guangzhou	Guangdong
China	The Third Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The Sixth People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	JiNan Infectious Diseases Hospital	Jinan	Shandong
China	No.81 Hospital of PLA	Nanjing	Jiangsu
China	Changhai Hospital affiliated to Second Military Medical University	Shanghai	Shanghai
China	Huashan Hospital,Fudan University	Shanghai	Shanghai
China	No.85 Hospital of PLA	Shanghai	Shanghai
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	ShengJing Hospital of China Medical University	Shengyang	Liaoning
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Tangdu Hospital	Xian	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Major Science and Technology Special Project of China Eleventh Five-year, Novartis

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II		Week 48	No
Secondary	Percentage of patients achieving HBV DNA <300copies/mL at week 156		Week 156	No
Secondary	The log10 reduction in HBV DNA from baseline of EFFORT study at week 156		Week 156	No
Secondary	Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156		Week 156	No
Secondary	Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156		Week 156	No
Secondary	The percentage of patients with ALT normalization at week 156		Week 156	No
Secondary	Percentage of patients with HBV DNA breakthrough at week 156		Week 156	No
Secondary	Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156		Week 156	No
Secondary	sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration		week 52 of off-treatment	No
Secondary	percentage of hepatitis flare at week 52 of off-treatment duration		week 52 of off-treatment	No