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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00640588 |
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine
Condition | Intervention | Phase |
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Hepatitis B, Chronic |
Drug: Telbivudine Drug: oral adefovir |
Phase III |
Study Type: | Interventional |
Study Design: | Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine |
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Telbivudine
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Drug: Telbivudine
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
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2: Active Comparator
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
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Drug: oral adefovir
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis | 41613241111 |
Spain | |
Novartis Investigative Site | Recruiting |
Barcelona, Spain | |
Contact: Novartis 41613241111 |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLDT600AES01 |
Study First Received: | March 17, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00640588 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Hepatitis B, chronic Viral kinetics Telbivudine Adefovir Compliance |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Antiviral Agents Reverse Transcriptase Inhibitors Hepatitis Virus Diseases |
Digestive System Diseases Anti-Retroviral Agents Hepatitis B, Chronic Hepatitis B DNA Virus Infections Adefovir dipivoxil Adefovir |
Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Hepatitis, Viral, Human Enzyme Inhibitors Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Hepatitis |
Virus Diseases Digestive System Diseases Anti-Retroviral Agents Therapeutic Uses Hepatitis B, Chronic Hepatitis B DNA Virus Infections Adefovir dipivoxil Adefovir Nucleic Acid Synthesis Inhibitors |