NCT01529255
Unknown
Phase 4
A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
ConditionsHepatitis B, Chronic
Overview
- Phase
- Phase 4
- Intervention
- telbivudine (ROADMAP)
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 576
- Locations
- 24
- Primary Endpoint
- The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
- Last Updated
- 11 years ago
Overview
Brief 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
Investigators
Eligibility 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
Arms & Interventions
ROADMAP
Intervention: telbivudine (ROADMAP)
SOC (Standard of Care)
Intervention: Telbivudine (Standard of Care)
Outcomes
Primary Outcomes
The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
Time Frame: Week 48
Secondary Outcomes
- Percentage of patients achieving HBV DNA <300copies/mL at week 156(Week 156)
- The log10 reduction in HBV DNA from baseline of EFFORT study at week 156(Week 156)
- Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156(Week 156)
- Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156(Week 156)
- The percentage of patients with ALT normalization at week 156(Week 156)
- Percentage of patients with HBV DNA breakthrough at week 156(Week 156)
- Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156(Week 156)
- sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration(week 52 of off-treatment)
- percentage of hepatitis flare at week 52 of off-treatment duration(week 52 of off-treatment)
Study Sites (24)
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