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

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Lamivudine

• Registration Number: NCT01376154
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2009-12
• Study Completion: 2011-02
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed lamivudine tablet	Lamivudine	Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period

Primary Outcome Measures

Name	Time	Method
Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet	6 months or more