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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
June 16, 2011
June 20, 2011
May 22, 2017
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 ]
Same as current
Complete list of historical versions of study NCT01376154 on ClinicalTrials.gov Archive Site
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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
Observational Model: Other
Time Perspective: Other
Not Provided
Not Provided
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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
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NCT01376154
112335
No
Not Provided
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GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2017