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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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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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

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