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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376154
• Other study ID #: 112335
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: May 19, 2017
• Start date: June 2006
• Est. completion date: February 2011

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: February 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Lamivudine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

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