Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks
Phase 4
Withdrawn
- Conditions
- Compensated Chronic Hepatitis B
- Interventions
- Drug: Telbivudine/LDT600A
- Registration Number
- NCT00862706
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Telbivudine/LDT600A -
- Primary Outcome Measures
Name Time Method non detectable HBV DNA level week 52
- Secondary Outcome Measures
Name Time Method Mean and median reduction in HBV DNA weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C Mean and median reduction from Baseline in absolute ALT level weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C Proportion of patients with ALT normalization weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C Proportion of patients with non-detectable serum HBV DNA week 24 of patients with HBeAg loss in subjects who were HBeAg positive at Baseline Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C Proportion of patients with HBeAg seroconversion in subjects who were HBeAg positive at Baseline 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C
Trial Locations
- Locations (6)
Liver Specialist of Texas
🇺🇸Houston, Texas, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Hepatobiliary Associates of New York
🇺🇸Bayside, New York, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Liver Associates of Texas
🇺🇸Houston, Texas, United States