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Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00131742
First received: August 18, 2005
Last updated: March 1, 2007
Last verified: March 2007
  Purpose

This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.


Condition Intervention Phase
Chronic Hepatitis B
Drug: telbivudine
Drug: lamivudine
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 Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Documented clinical history compatible with chronic hepatitis B infection

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
  • Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog

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: NCT00131742

Locations
China
Beijing, China
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Novartis
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131742     History of Changes
Other Study ID Numbers: NV-02B-015
Study First Received: August 18, 2005
Last Updated: March 1, 2007
Health Authority: United States: Food and Drug Administration
China: 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