An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
This study has been completed.
Sponsor:
Novartis
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00124241
First received: July 25, 2005
Last updated: February 9, 2015
Last verified: March 2007
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Purpose
This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: telbivudine Drug: lamivudine |
Phase 2 |
| 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 Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
- Patient remains seropositive for hepatitis B surface antigen (HBsAg)
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breast-feeding
- Patient has signs of decompensated chronic hepatitis B
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124241
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124241
Locations
| United States, California | |
| Los Angeles, California, United States | |
| Canada | |
| Toronto, Canada | |
| China | |
| Hong Kong, China | |
| France | |
| Paris, France | |
Sponsors and Collaborators
Novartis
Novartis Pharmaceuticals
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00124241 History of Changes |
| Other Study ID Numbers: | NV-02B-010 |
| Study First Received: | July 25, 2005 |
| Last Updated: | February 9, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic DNA Virus Infections Digestive System Diseases Enterovirus Infections Hepadnaviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections RNA Virus Infections |
Virus Diseases Lamivudine Telbivudine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015