HEPSERA Post Marketing Surveillance (HEPSERA PMS)
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|ClinicalTrials.gov Identifier: NCT01329419|
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : April 5, 2011
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment|
|Hepatitis B||Drug: adefovir dipivoxil|
|Study Type :||Observational|
|Actual Enrollment :||4393 participants|
|Official Title:||A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Patients administrated adefovir at the site
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.
- Number of Participants With an Adverse Event [ Time Frame: 12 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.
- Number of Participants With a Serious Adverse Event [ Time Frame: 12 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.
- Number of Participants With the Indicated Unexpected Adverse Events [ Time Frame: 12 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329419
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|