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

NCT ID: NCT01376154

Last Updated: 2017-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

342 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Subjects prescribed lamivudine tablet

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

Lamivudine

Intervention Type DRUG

Interventions

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Lamivudine

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112335

Identifier Type: -

Identifier Source: org_study_id

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