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

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

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

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)

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Peginterferon Alfa-2b

U.S. FDA Resources

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
Study Completion Date:	October 2009
Primary Completion Date:	October 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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02570
Study First Received:	November 14, 2002
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00049842 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Hepatitis, Chronic
Flaviviridae Infections
Fibrosis
Hepatitis, Viral, Human
Liver Cirrhosis
Antiviral Agents

Pharmacologic Actions
Hepatitis
Virus Diseases
Pathologic Processes
Digestive System Diseases
Therapeutic Uses
Peginterferon alfa-2b
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 27, 2009