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

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ClinicalTrials.gov Identifier: NCT01376154
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment
Hepatitis B, Chronic Drug: Lamivudine

Study Type : Observational
Actual Enrollment : 342 participants
Observational Model: Other
Time Perspective: Other
Official Title: Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)
Study Start Date : June 2006
Primary Completion Date : December 2009
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects prescribed lamivudine tablet
Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period
Drug: Lamivudine



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


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

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376154     History of Changes
Other Study ID Numbers: 112335
First Posted: June 20, 2011    Key Record Dates
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