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HEPSERA Post Marketing Surveillance (HEPSERA PMS)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01329419
First received: March 10, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 10, 2011
March 10, 2011
August 2004
February 2010   (final data collection date for primary outcome measure)
Number of Participants With an Adverse Event [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
  • Number of Participants With a Serious Adverse Event [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With the Indicated Unexpected Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
HEPSERA Post Marketing Surveillance
A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients administrated adefovir dipivoxil at the site

Hepatitis B
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.
adefovir dipivoxil
Patients administrated adefovir at the site
Intervention: Drug: adefovir dipivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4393
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients administrated adefovir dipivoxil at the site

Exclusion Criteria:

  • Patients administrated adefovir dipivoxil before center initiated date
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01329419
105711
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP