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Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
This study has been completed.
Sponsor:
Novartis
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00115245
First received: June 21, 2005
Last updated: May 8, 2015
Last verified: May 2015
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Purpose
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Hepatitis B | Drug: Telbivudine (LdT) Drug: Adefovir Dipivoxil | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B |
Resource links provided by NLM:
Further study details as provided by Novartis:
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
Criteria
Inclusion Criteria:
- Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
- Detectable serum HBsAg at the Screening visit
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breastfeeding.
- Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
- Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
- Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
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: NCT00115245
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115245
Locations
| United States, California | |
| Los Angeles, California, United States | |
| Pasadena, California, United States | |
| San Francisco, California, United States | |
| United States, Florida | |
| Miami, Florida, United States | |
| Australia | |
| Clayton, Australia | |
| Wooloongabba, Australia | |
| Canada | |
| Calgary, Canada | |
| Toronto, Canada | |
| Winnipeg, Canada | |
| China | |
| Hong Kong, China | |
| France | |
| Paris, France | |
| Korea, Republic of | |
| Seoul, Korea, Republic of | |
| Singapore | |
| Singapore, Singapore | |
| Taiwan | |
| Taipei, Taiwan | |
| Thailand | |
| Bangkok, Thailand | |
Sponsors and Collaborators
Novartis
Novartis Pharmaceuticals
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00115245 History of Changes |
| Other Study ID Numbers: |
NV-02B-018 |
| Study First Received: | June 21, 2005 |
| Last Updated: | May 8, 2015 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B 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 Adefovir dipivoxil Adefovir Telbivudine Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 23, 2017