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
Results First Received: March 10, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis B
Intervention: Drug: adefovir dipivoxil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Hepsera in the real clinical setting after launch.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Hepsera 10 mg Once a Day Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily

Participant Flow:   Overall Study
    Hepsera 10 mg Once a Day  
STARTED     4393  
COMPLETED     4158  
NOT COMPLETED     235  
Protocol Violation                 235  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Hepsera 10 mg Once a Day Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily

Baseline Measures
    Hepsera 10 mg Once a Day  
Number of Participants  
[units: participants]
  4158  
Age [1]
[units: Years]
Mean ± Standard Deviation
  43.9  ± 11  
Gender, Customized [2]
[units: Participants]
 
Female     874  
Male     3280  
Missing     4  
Race/Ethnicity, Customized [2]
[units: participants]
 
Korean     4158  
Not Korean     0  
[1] Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments.
[2] Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments.



  Outcome Measures
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1.  Primary:   Number of Participants With an Adverse Event   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Participants With a Serious Adverse Event   [ Time Frame: 12 weeks ]

3.  Secondary:   Number of Participants With the Indicated Unexpected Adverse Events   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01329419     History of Changes
Other Study ID Numbers: 105711
Study First Received: March 10, 2011
Results First Received: March 10, 2011
Last Updated: March 10, 2011
Health Authority: Korea: Food and Drug Administration