An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant
Overview
- Phase
- Phase 3
- Intervention
- telbivudine
- Conditions
- Hepatitis B
- Sponsor
- Novartis
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- The Proportion of Participants Who Experienced Virologic Breakthrough
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
- •Previous or current lamivudine treatment
- •HBV DNA \> 6 log10 copies/mL
- •Evidence of viral breakthrough
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Patient is pregnant or breastfeeding.
- •Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
- •Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
Combination therapy
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
Intervention: telbivudine
Combination therapy
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
Intervention: adefovir dipivoxil
Adefovir monotherapy
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Intervention: adefovir dipivoxil
Outcomes
Primary Outcomes
The Proportion of Participants Who Experienced Virologic Breakthrough
Time Frame: 96 Weeks
Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.
Secondary Outcomes
- Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration(Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks)
- Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria(12 week, 24 week, 48 week and 60 weeks)
- Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough(Week 96)