Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)

This study has been completed.

Study NCT00049842 Information provided by Schering-Plough

First Received on November 14, 2002. Last Updated on March 25, 2011 History of Changes

Results First Received: October 7, 2010

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

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
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)	PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
Untreated Control	Participants were observed (no treatment given) for 36 months with 4-week follow-up

Participant Flow for 2 periods

Period 1: Treatment Phase

	PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)	Untreated Control
STARTED	270	270
COMPLETED	177	192
NOT COMPLETED	93	78
Adverse Event	47	12
Withdrawal by Subject	35	46
Non-compliance with protocol	7	8
Lost to Follow-up	4	8
Administrative	0	3
Did not meet protocol eligibility	0	1

Period 2: Follow-up Phase

	PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)	Untreated Control
STARTED	218 ^[1]	194 ^[1]
COMPLETED	211	189
NOT COMPLETED	7	5
Adverse Event	6	1
Not specified	1	4

[1]	Population is all treatment phase completers plus some who discontinued the treatment phase.

Baseline Characteristics

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Reporting Groups

	Description
PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)	PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
Untreated Control	Participants were observed (no treatment given) for 36 months with 4-week follow-up

Baseline Measures

	PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)	Untreated Control	Total
Number of Participants [units: participants]	270	270	540
Age, Customized [units: participants]
<=50 years	145	148	293
>50 years	125	122	247
Gender [units: participants]
Female	76	81	157
Male	194	189	383

Outcome Measures

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1. Primary:

Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). [ Time Frame: Baseline to up to Month-36 ]

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2. Secondary:

Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline) [ Time Frame: Baseline to up to Month-36 ]

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3. Secondary:

Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ]

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4. Secondary:

The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline [ Time Frame: Baseline to up to Month-36 ]

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5. Secondary:

Mean Change in the METAVIR Activity Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ]

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6. Secondary:

Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment. [ Time Frame: Baseline to up to Month-36 ]

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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: No public presentation/publication of any interim results will be made by any principal investigator (PI) or any other member of the study staff without the Sponsor's prior written consent. The PI further agrees to provide to the sponsor 30 days prior to submission, review copies that report any results of the study. The sponsor shall have the right to review, comment, and edit. If the parties disagree, the PI agrees to meet with the sponsor to discuss and resolve any such issues/disagreement.

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:	NCT00049842 History of Changes
Other Study ID Numbers:	P02570
Study First Received:	November 14, 2002
Results First Received:	October 7, 2010
Last Updated:	March 25, 2011
Health Authority:	United States: Food and Drug Administration