An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
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ClinicalTrials.gov Identifier: NCT00124241 |
Recruitment Status :
Completed
First Posted : July 27, 2005
Last Update Posted : May 12, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B | Drug: telbivudine Drug: lamivudine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Actual Primary Completion Date : | February 2003 |
Actual Study Completion Date : | November 2005 |


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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124241
United States, California | |
Los Angeles, California, United States | |
Canada | |
Toronto, Canada | |
China | |
Hong Kong, China | |
France | |
Paris, France |
ClinicalTrials.gov Identifier: | NCT00124241 |
Other Study ID Numbers: |
NV-02B-010 |
First Posted: | July 27, 2005 Key Record Dates |
Last Update Posted: | May 12, 2015 |
Last Verified: | May 2015 |
Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases |
Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic Lamivudine Telbivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents |