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Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376154
First Posted: June 20, 2011
Last Update Posted: May 22, 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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.

Condition Intervention
Hepatitis B, Chronic Drug: Lamivudine

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet [ Time Frame: 6 months or more ]

Enrollment: 342
Study Start Date: June 2006
Study Completion Date: February 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed lamivudine tablet
Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period
Drug: Lamivudine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer.
Criteria

Inclusion Criteria:

  • Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer

Exclusion Criteria:

  • Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet
  • Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet
  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): NCT01376154


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376154     History of Changes
Other Study ID Numbers: 112335
First Submitted: June 16, 2011
First Posted: June 20, 2011
Last Update Posted: May 22, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Lamivudine
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