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

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C Liver Fibrosis	Biological: peginterferon alfa-2b (SCH 54031)	Phase III

MedlinePlus related topics:

Hepatitis Hepatitis C

ChemIDplus related topics:

Ribavirin Interferon alfa-2b Interferons Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	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)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	700
Study Start Date:	October 2002
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PegIntron (peginterferon alfa-2b) 0.5 µg/kg QW: Experimental PegIntron 0.5 µg/kg QW SC as maintenance therapy for 36 months with 4-week follow-up	Biological: peginterferon alfa-2b (SCH 54031) 0.5 µg/kg QW SC for 36 months
Untreated Control: No Intervention

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049842

Show 121 Study Locations

Sponsors and Collaborators

Schering-Plough

Investigators


Study Director:	Margaret H Burroughs, MD	Schering-Plough

Study Director:	Louis H Griffel, MD	Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Janice Albrecht, PhD - Vice President, Global Clinical Research, Hepatology )
Study ID Numbers:	P02570
First Received:	November 14, 2002
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00049842
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Liver Diseases

Hepatic fibrosis

Hepatitis, Chronic

Fibrosis

Interferons

Ribavirin

Disease Progression

Hepatitis, Viral, Human

Liver Cirrhosis

Hepatitis

Virus Diseases

Digestive System Diseases

Peginterferon alfa-2b

Hepatitis C

Interferon Alfa-2b

Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Pathologic Processes

Flaviviridae Infections

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00049842