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

GlaxoSmithKline342 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

342

Conditions

Hepatitis B, Chronic

Interventions

LamivudineDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet

Time frame: 6 months or more

Data from ClinicalTrials.gov

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