Status:
WITHDRAWN
Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking ad...
Eligibility Criteria
Inclusion
- Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
- Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.
- Other inclusion criteria may apply.
Exclusion
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis C, hepatitis D or HIV
- Patient previously received nucleoside(tide) therapy other than adefovir
- Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months
- Other exclusion criteria may apply.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00409019
Last Update
March 9 2015
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