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Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00132652
First Posted: August 22, 2005
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: Double
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 Novartis:

Estimated Enrollment: 240
Study Start Date: February 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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
Novartis
Novartis Pharmaceuticals
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00132652     History of Changes
Other Study ID Numbers: NV-02B-019
First Submitted: August 18, 2005
First Posted: August 22, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017

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
Lamivudine
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents