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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
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Hepatitis B Drug: adefovir dipivoxil

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.

Study Type : Observational
Actual Enrollment : 4393 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
adefovir dipivoxil
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated adefovir dipivoxil at the site
Criteria

Inclusion Criteria:

  • Patients administrated adefovir dipivoxil at the site

Exclusion Criteria:

  • Patients administrated adefovir dipivoxil before center initiated date

Information from the National Library of Medicine

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


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01329419     History of Changes
Other Study ID Numbers: 105711
First Posted: April 5, 2011    Key Record Dates
Results First Posted: April 5, 2011
Last Update Posted: July 5, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents