Drug Use Investigation for HEPSERA (Adefovir) Tablet

Completed

• Conditions: Hepatitis B
• Interventions: Drug: Adefovir tablets

• Registration Number: NCT01863589
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2007-06
• Study Completion: 2012-07
• Study First Submitted: 2012-10-04
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-23
• Last Update Submitted: 2013-05-23
• Study First Posted: 2013-05-29
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

• Subjects with chronic hepatitis B or hepatic cirrhosis B
• Subjects treated with adefovir tablets

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed adefovir tablets	Adefovir tablets	Subjects with chronic hepatitis B or hepatic cirrhosis B to whom adefovir tablets are administered

Primary Outcome Measures

Name	Time	Method
The incidence of adverse drug reactions	1 year