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

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ClinicalTrials.gov Identifier: NCT00132652
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Lamivudine Drug: Telbivudine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00132652     History of Changes
Other Study ID Numbers: NV-02B-019
First Posted: August 22, 2005    Key Record Dates
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