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

Tracking Information
First Received Date ^ICMJE	November 14, 2002
Last Updated Date	October 29, 2009
Start Date ^ICMJE	October 2002
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	To compare the PegIntron-treated group vs untreated control with respect to the fibrosis response status (ie, either improving the fibrosis score or preventing the worsening of the fibrosis score in subjects with METAVIR fibrosis score of F2 or F3). [ Time Frame: 36-month treatment or observation (untreated control); 4-week follow-up ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00049842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	For subjects with paired biopsies: the change in METAVIR fibrosis score between baseline and at the end of the 36-month treatment. The proportion of subjects whose METAVIR fibrosis score did not worsen during treatment compared to baseline. [ Time Frame: 36-month treatment or observation (untreated control); 4-week follow-up ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
Official Title ^ICMJE	PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370)
Brief Summary	The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of fibrosis progression in adult subjects with moderate to severe liver fibrosis secondary to chronic hepatitis, who failed PEG-Intron plus Rebetol treatment in protocol P02370.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Hepatitis C Liver Fibrosis
Intervention ^ICMJE	Biological: peginterferon alfa-2b (SCH 54031)
Study Arms / Comparison Groups	Experimental: PegIntron 0.5 µg/kg QW SC as maintenance therapy for 36 months with 4-week follow-up
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	700
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age at entry in study P02370 18-65 years; Nonresponder to PEG-Intron plus Rebetol in study P02370 Exclusion Criteria: Patients who did not participate in the P02370 study.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00049842
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P02570
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP