HEPSERA Post Marketing Surveillance

Hepatitis B Clinical Trial

— HEPSERA PMS  

Official title:

A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329419
• Other study ID #: 105711
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: March 10, 2011
• Start date: August 2004
• Est. completion date: February 2010

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 4393
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients administrated adefovir dipivoxil at the site

Exclusion Criteria:

• Patients administrated adefovir dipivoxil before center initiated date

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• adefovir dipivoxil
Basically there is no treatment allocation. Subjects who would be administered of adefovir at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Adverse Event	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.	12 weeks	No
Secondary	Number of Participants With a Serious Adverse Event	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.	12 weeks	No
Secondary	Number of Participants With the Indicated Unexpected Adverse Events	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.	12 weeks	No