Status:
TERMINATED
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
Lead Sponsor:
Novartis
Conditions:
Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00376259
Start Date
January 1 2007
Last Update
June 30 2011
Active Locations (6)
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1
Novartis
San Diego, California, United States
2
San Mateo, California, United States
3
Pok Fu Lam, Hong Kong
4
Seoul, South Korea