Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
This study has been completed.
Sponsor:
Idenix Pharmaceuticals
Collaborator:
Novartis
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00132652
First received: August 18, 2005
Last updated: November 14, 2007
Last verified: November 2007
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Purpose
This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: Lamivudine Drug: Telbivudine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B |
Resource links provided by NLM:
Further study details as provided by Idenix Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented clinical history compatible with chronic hepatitis B
- Patient has compensated liver disease
- Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis C, hepatitis D or HIV
- Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132652
Locations
| United States, California | |
| San Diego, California, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Australia | |
| Westmead, Australia | |
| Canada, Ontario | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal, Quebec, Canada | |
| China | |
| Beijing, China | |
| France | |
| Nice, France | |
| Israel | |
| Tel Aviv, Israel | |
| New Zealand | |
| Auckland, New Zealand | |
| Singapore | |
| Singapore, Singapore | |
| Taiwan | |
| Tainan, Taiwan | |
| Thailand | |
| Chiang Mai, Thailand | |
| United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Idenix Pharmaceuticals
Novartis
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00132652 History of Changes |
| Other Study ID Numbers: | NV-02B-019 |
| Study First Received: | August 18, 2005 |
| Last Updated: | November 14, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 16, 2013