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

June 16, 2011
June 16, 2011
June 2006
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)
Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

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.

Not Provided
Observational
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Probability Sample

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.

Hepatitis B, Chronic
Drug: Lamivudine
Subjects prescribed lamivudine tablet
Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period
Intervention: Drug: Lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
342
February 2011
December 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01376154
112335
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP