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| Sponsors and Collaborators: |
Novartis Idenix Pharmaceuticals |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00412529 |
Purpose
This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple timepoints over 12 weeks
| Condition | Intervention | Phase |
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Hepatitis B, Chronic |
Drug: telbivudine Drug: entecavir |
Phase III |
| MedlinePlus related topics: | Hepatitis Hepatitis B |
| ChemIDplus related topics: | Hepatitis B Vaccines Entecavir Telbivudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-Positive, Compensated Chronic Hepatitis B (CHB) |
| Enrollment: | 43 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | March 2008 |
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CLDT600A2407 |
| First Received: | December 15, 2006 |
| Last Updated: | November 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00412529 |
| Health Authority: | Korea: Food and Drug Administration; United States: Food and Drug Administration |
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