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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:
Collaborator:
Novartis
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00132652
First received: August 18, 2005
Last updated: November 14, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Merck Sharp & Dohme Corp.:

Estimated Enrollment: 240
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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
Merck Sharp & Dohme Corp.
Novartis
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00132652     History of Changes
Other Study ID Numbers: NV-02B-019
Study First Received: August 18, 2005
Last Updated: November 14, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
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 November 25, 2014