Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569AM2)(COMPLETED) - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Parallel Assignment
Conditions:	Chronic Hepatitis C Cirrhosis
Intervention:	Biological: peginterferon alfa-2b (SCH 54031)

Participant Flow

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
Analysis population is modified intent to treat (MITT), comprising 626 randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from analyses.

Reporting Groups

	Description
PegIntron	PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control	No text entered.

Participant Flow: Overall Study

	PegIntron	Untreated Control
STARTED	311	315
COMPLETED	195	197
NOT COMPLETED	116	118
Adverse Event	53	12
Withdrawal by Subject	34	54
Lost to Follow-up	5	5
Protocol-defined Clinical Event	17	32
Noncompliance With Protocol	4	12
Did Not Meet Protocol Eligibility	2	2
Administrative	1	1

Baseline Characteristics

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Reporting Groups

	Description
PegIntron	PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control	No text entered.

Baseline Measures

	PegIntron	Untreated Control	Total
Number of Participants [units: participants]	311	315	626
Age, Customized [units: Participants]
<=50 years	130	132	262
>50 years	181	183	364
Gender [units: Participants]
Female	105	100	205
Male	206	215	421

Outcome Measures

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1. Primary:

Time to Observation of the First Clinical Event Experienced by a Subject [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]

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Measure Type	Primary
Measure Title	Time to Observation of the First Clinical Event Experienced by a Subject
Measure Description	Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation
Time Frame	Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
Safety Issue	Yes

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.
Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.

Reporting Groups

	Description
PegIntron	PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control	No text entered.

Measured Values

	PegIntron	Untreated Control
Number of Participants Analyzed [units: participants]	311	315
Time to Observation of the First Clinical Event Experienced by a Subject [units: Participants]
<=6 Months	3	2
>6 to 12 Months	5	5
>12 to 18 Months	4	4
>18 to 24 Months	3	7
>24 to 30 Months	7	6
>30 to 36 Months	1	6
>36 to 42 Months	0	5
>42 to 48 Months	2	0
>48 to 54 Months	2	1
>54 to 60 Months	0	0
Total Over Study	27	36

Statistical Analysis 1 for Time to Observation of the First Clinical Event Experienced by a Subject

Groups ^[1]	All groups
Method ^[2]	Cox Proportional Hazards Model
P Value ^[3]	0.1439
Hazard Ratio (HR) ^[4]	1.452
95% Confidence Interval	( 0.880 to 2.396 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Age (<= 50 years, >50 years) and participation in a prior study (yes, no) were stratification factors.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Hazard ratio represents results of untreated control relative to treatment.

2. Secondary:

Time to Observation of the Disease Progression Experienced by a Subject [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]

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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: The investigator agrees to provide review copies to the sponsor 30 days prior to submission for publication or presentation. The sponsor shall have editorial rights and the right to review and comment on the data analysis and presentation. If the parties disagree, investigator agrees to meet with the sponsor's representatives for the purpose of making good faith efforts to discuss and resolve any such issues.

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
No text entered.

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 )
Study ID Numbers:	P02569
Study First Received:	November 6, 2002
Results First Received:	April 23, 2009
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00048724 History of Changes
Health Authority:	United States: Food and Drug Administration