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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376154
First received: June 16, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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
Official Title: Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

Resource links provided by NLM:

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

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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376154

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01376154     History of Changes
Other Study ID Numbers: 112335
Study First Received: June 16, 2011
Last Updated: June 16, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Fibrosis
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
 Pathologic Processes
Hepatitis, Chronic
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013