EFFORT Extension Study (EFFORT-Ex)

This study is ongoing, but not recruiting participants.
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: June 17, 2014
Last verified: June 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529255

Locations
China, Beijing
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
People's Hospital Under Beijnig University
Beijing, Beijing, China
Department of Infectious Disease, First Hospital of Peking University
Beijing, Beijing, China
China, Chongqing
The Second Affiliated of ChongQing University of Medical Science
Chongqing, Chongqing, China
China, Guangdong
No. 8 People's Hospital In GuangZhou
Guangzhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Department of Infectious Disease, Nanfang Hospital
Guangzhou, Guangdong, China
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Hunan
Xiangya Hospital Central-South Univrsity
Changsha, Hunan, China
China, Jiangsu
No.81 Hospital of PLA
Nanjing, Jiangsu, China
China, Jilin
First Hospital .Jilin Unniversity
Changchun, Jilin, China
China, Liaoning
ShengJing Hospital of China Medical University
Shengyang, Liaoning, China
China, Shandong
JiNan Infectious Diseases Hospital
Jinan, Shandong, China
China, Shanghai
No.85 Hospital of PLA
Shanghai, Shanghai, China
Huashan Hospital,Fudan University
Shanghai, Shanghai, China
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai, China
Shanghai Ruijin Hospital
Shanghai, Shanghai, China
China, Shanxi
Tangdu Hospital
Xian, Shanxi, China
China, Sichuan
West China Hospital.SiChuan University
Chengdu, Sichuan, China
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The Sixth People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
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: June 17, 2014
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
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Telbivudine
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014