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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hepatitis B, Chronic

Treatments: Drug: Lamivudine

Study type: Observational

Funder types: Industry

Identifiers

NCT01376154

112335

Details and patient eligibility

About

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.

Enrollment: 342 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

342 participants in 1 patient group

Subjects prescribed lamivudine tablet

Description:

Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period

Treatment:

Drug: Lamivudine