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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01376154

Enrollment

342

Registered

2011-06-20

Start date

2006-06-30

Completion date

2011-02-28

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

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.

Interventions

DRUGLamivudine

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026