Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00202839

First received: September 12, 2005

Last updated: February 25, 2011

Last verified: February 2011

History of Changes

Results First Received: August 28, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hepatitis C, Chronic
Interventions:	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: Ribavirin

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
24-Week Treatment	Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
48-Week Treatment	Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)

Participant Flow: Overall Study

	24-Week Treatment	48-Week Treatment
STARTED	78	82
COMPLETED	54	72
NOT COMPLETED	24	10
Adverse Event	1	5
Physician Decision	12	0
Withdrawal by Subject	6	2
Protocol Violation	2	1
Lost to Follow-up	3	2

Baseline Characteristics

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Reporting Groups

	Description
24-Week Treatment	Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
48-Week Treatment	Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
Total	Total of all reporting groups

Baseline Measures

	24-Week Treatment	48-Week Treatment	Total
Number of Participants [units: participants]	78	82	160
Age [units: years] Mean ± Standard Deviation	50.63 ± 10.6	50.46 ± 10.93	50.55 ± 10.74
Gender [units: participants]
Female	20	39	59
Male	58	43	101
Region of Enrollment [units: participants]
Taiwan	78	82	160

Outcome Measures

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1. Primary:

The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR) [ Time Frame: 24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy ]

Measure Type	Primary
Measure Title	The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)
Measure Description	Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy
Time Frame	24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy
Safety Issue	No

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.
Intention to treat [ITT] population defined as participants who received at least one dose of study medication.

Reporting Groups

	Description
24-Week Treatment	Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
48-Week Treatment	Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)

Measured Values

	24-Week Treatment	48-Week Treatment
Number of Participants Analyzed [units: participants]	78	82
The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR) [units: Percentage of participants]	56.41	67.07

Statistical Analysis 1 for The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.1651

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2. Secondary:

The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization. [ Time Frame: 48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization) ]

Measure Type	Secondary
Measure Title	The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.
Measure Description	Virologic response was defined as undetectable HCV-RNA level in the blood.
Time Frame	48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)
Safety Issue	No

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.
Intention to treat [ITT] population

Reporting Groups

	Description
24-Week Treatment	Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
48-Week Treatment	Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)

Measured Values

	24-Week Treatment	48-Week Treatment
Number of Participants Analyzed [units: participants]	78	82
The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization. [units: Percentage of Participants]	57.69	67.07

No statistical analysis provided for The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.

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 further agree to provide forty-five (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@merck.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00202839 History of Changes
Other Study ID Numbers:	P04144
Study First Received:	September 12, 2005
Results First Received:	August 28, 2009
Last Updated:	February 25, 2011
Health Authority:	Taiwan: Department of Health

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