PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370AM2)(COMPLETED)

This study has been completed.

Study NCT00039871 Information provided by Schering-Plough

First Received: June 13, 2002 Last Updated: October 13, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Conditions:	Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis
Interventions:	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)

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
Enrolled 2333; 21 subjects excluded due to Good Clinical Practice (GCP) non-compliance.

Reporting Groups

	Description
PegIntron Plus Rebetol	No text entered.

Participant Flow: Overall Study

	PegIntron Plus Rebetol
STARTED	2312^[1]
COMPLETED	928
NOT COMPLETED	1384
Adverse Event	165
Lost to Follow-up	18
Protocol Violation	24
Withdrawal by Subject	97
Did not meet eligibility criteria	11
Administrative	1
Discontinued at Week 12 per protocol	1061
Never entered follow-up	7

[1]	Enrolled 2333; 21 subjects excluded due to GCP non-compliance

Baseline Characteristics

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Reporting Groups

	Description
PegIntron Plus Rebetol	No text entered.

Baseline Measures

	PegIntron Plus Rebetol
Number of Participants [units: participants]	2312
Age [units: number of subjects]
<=18 years	0
Between 18 and 65 years	2267
>=65 years	45
Age [units: years] Mean ± Standard Deviation	49.2 ± 8.1
Gender [units: number of subjects]
Female	662
Male	1650
Hepatitis C Virus (HCV) Genotype [units: number of participants]
Genotype 1	1859
Genotype 2	75
Genotype 3	293
Genotype 4	68
Nontypable	8
Missing	9
METAVIR Fibrosis score^[1] [units: number of participants]
F1	2
F2	658
F3	676
F4	974
Missing	2

[1]	The METAVIR scoring system for hepatic fibrosis is as follows: F0= no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3= septal fibrosis without cirrhosis F4= cirrhosis

Outcome Measures

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1. Primary:

Sustained Virologic Response (SVR) Rate [ Assessed at end of 24 weeks posttreatment follow-up ]

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Measure Type	Primary
Measure Title	Sustained Virologic Response (SVR) Rate
Measure Description	Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
Time Frame	Assessed at end of 24 weeks posttreatment follow-up
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.
Participants who received at least one dose of study medication

Reporting Groups

	Description
PegIntron Plus Rebetol	No text entered.

Measured Values

	PegIntron Plus Rebetol
Number of Participants Analyzed [units: participants]	2293
Sustained Virologic Response (SVR) Rate [units: Participants]	497

Statistical Analysis 1 for Sustained Virologic Response (SVR) Rate

Groups ^[1]	PegIntron Plus Rebetol
Binomial Approximation ^[2]	0.217
99% Confidence Interval	( 0.195 to 0.239 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	No text entered.

2. Secondary:

Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 [ 24 weeks posttreatment ]

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3. Secondary:

Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 [ 24 weeks posttreatment ]

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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.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02370
Study First Received:	June 13, 2002
Results First Received:	September 29, 2008
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00039871 History of Changes
Health Authority:	United States: Food and Drug Administration