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| Sponsored by: |
Novartis |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00409019 |
Purpose
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 adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.
| Condition | Intervention | Phase |
|
Chronic Hepatitis B |
Drug: Telbivudine Drug: Adefovir Drug: Tenofovir |
Phase IV |
| MedlinePlus related topics: | Hepatitis Hepatitis B |
| Drug Information available for: | Hepatitis B Vaccines Adefovir dipivoxil Adefovir Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Telbivudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study) |
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Other inclusion criteria may apply.
Exclusion Criteria:
Other exclusion criteria may apply.
Contacts and Locations More Information
| Responsible Party: | novatis ( novartis ) |
| Study ID Numbers: | CLDT600AUS05 |
| First Received: | December 7, 2006 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00409019 |
| Health Authority: | United States: Food and Drug Administration |
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