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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
History of Changes

September 20, 2011
April 21, 2013
August 2011
August 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01529255 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of patients achieving HBV DNA <300copies/mL at week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • 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 week48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • The log10 reduction in HBV DNA from baseline of EFFORT study at week 96 [ Time Frame: Week 96 ] [ 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 ]
  • The log10 reduction in quantitative HBsAg and HBeAg from baseline in EFFORT study at week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • The log10 reduction in quantitative HBsAg and HBeAg from baseline in EFFORT study at week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • The log10 reduction in quantitative HBsAg and HBeAg from baseline in 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 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg loss or HBeAg seroconversion at week 96 [ Time Frame: Week 96 ] [ 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 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBsAg loss or HBsAg seroconversion at week 96 [ Time Frame: Week 96 ] [ 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 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • The percentage of patients with ALT normalization at week 96 [ Time Frame: Week 96 ] [ 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 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBV DNA breakthrough at week 96 [ Time Frame: Week 96 ] [ 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 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 96 [ Time Frame: Week 96 ] [ 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 ]
  • percantage of patients with creatine kinase elevation at week 48 [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
  • percantage of patients with creatine kinase elevation at week 96 [ Time Frame: week 96 ] [ Designated as safety issue: Yes ]
  • percantage of patients with creatine kinase elevation at week 156 [ Time Frame: week 156 ] [ Designated as safety issue: Yes ]
  • percantage of patients with creatinine elevation at week 48 [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
  • percantage of patients with creatinine elevation at week 96 [ Time Frame: week 96 ] [ Designated as safety issue: Yes ]
  • percantage of patients with creatinine elevation at week 156 [ Time Frame: week 156 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
EFFORT Extension Study
A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
  • 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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • 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.

  • 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.
  • Experimental: ROADMAP
    Intervention: Drug: telbivudine (ROADMAP)
  • Active Comparator: SOC (Standard of Care)
    Intervention: Drug: Telbivudine (Standard of Care)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
576
December 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Jinlin Hou, MD 86-20-61641941 jlhousmu@yahoo.com.cn
Contact: Jian Sun 86-20-62787432 sunjian@fimmu.com
China
 
NCT01529255
MOH-05
Yes
Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
  • Major Science and Technology Special Project of China Eleventh Five-year
  • Novartis
Principal Investigator: Jinlin Hou, MD Nanfang Hospital,Southern Medical University
Nanfang Hospital of Southern Medical University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP