MedPath

HEPSERA Post Marketing Surveillance

Completed
Conditions
Hepatitis B
Interventions
Registration Number
NCT01329419
Lead Sponsor
GlaxoSmithKline
Brief Summary

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information

Detailed Description

This study is a post-marketing surveillance to monitor safety and efficacy of adefovir dipivoxil and identify SAEs, adverse drug reactions (ADRs), and unexpected AEs not described as precautions or warnings and to identify possible factors that have an effect on the AEs and to assess effectiveness of adefovir dipivoxil in real clinical practices after marketing. The subjects are patients prescribed for adefovir dipivoxil by the investigators at the sites based on prescription information in normal clinical practices.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4393
Inclusion Criteria
  • Patients administrated adefovir dipivoxil at the site
Exclusion Criteria
  • Patients administrated adefovir dipivoxil before center initiated date

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
adefovir dipivoxiladefovir dipivoxilPatients administrated adefovir at the site
Primary Outcome Measures
NameTimeMethod
Number of Participants With an Adverse Event12 weeks

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With the Indicated Unexpected Adverse Events12 weeks

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.

Number of Participants With a Serious Adverse Event12 weeks

A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.

© Copyright 2025. All Rights Reserved by MedPath