PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)(COMPLETED)

This study has been completed.

Study NCT00371761 Information provided by Schering-Plough

First Received on August 31, 2006. Last Updated on November 18, 2010 History of Changes

Results First Received: July 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hepatitis B, Chronic (CHB)
Interventions:	Drug: Pegylated interferon alfa-2b (PegIntron) Drug: Adefovir dipivoxil (adefovir)

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
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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
PegIntron	PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
Adefovir	Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase

Participant Flow: Overall Study

	PegIntron	Adefovir
STARTED	13	12
COMPLETED	5	2
NOT COMPLETED	8	10
Adverse Event	1	1
Withdrawal by Subject	1	3
Investigator Judgment	2	3
Study termination	4	3

Baseline Characteristics

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Reporting Groups

	Description
PegIntron	PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
Adefovir	Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase

Baseline Measures

	PegIntron	Adefovir	Total
Number of Participants [units: participants]	13	12	25
Age [units: years] Mean ± Standard Deviation	36.7 ± 8.5	36.7 ± 13.6	36.7 ± 11.0
Gender [units: participants]
Female	4	1	5
Male	9	11	20
Region of Enrollment [units: participants]
Taiwan	13	12	25

Outcome Measures

1. Primary:

Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response [ Time Frame: At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 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: Principal Investigator and Institution agree not to publish or publicly present any interim results of the study. Principal Investigator and Institution further agree to provide 45 days written notice to Sponsor prior to submission for publication or presentation to permit Sponsor to review drafts of abstracts and manuscripts for publication.

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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00371761 History of Changes
Other Study ID Numbers:	P04498
Study First Received:	August 31, 2006
Results First Received:	July 15, 2010
Last Updated:	November 18, 2010
Health Authority:	Taiwan: Department of Health