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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00048724

Purpose

The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Peginterferon Alfa-2b Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	631
Study Start Date:	June 2002
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PegIntron PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up	Biological: peginterferon alfa-2b (SCH 54031) 0.5 µg/kg subcutaneously once weekly for 60 months Other Name: PegIntron
No Intervention: Untreated Control

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 18-65 years;
Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
Liver biopsy demonstrating cirrhosis

Exclusion Criteria:

Any other cause for liver disease other than chronic hepatitis C;
History or presence of complications of cirrhosis;
Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
Diseases or conditions that could interfere with participation in the study

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group. Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1990-9. Epub 2011 Mar 17.

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00048724 History of Changes
Other Study ID Numbers:	P02569
Study First Received:	November 6, 2002
Results First Received:	April 23, 2009
Last Updated:	October 13, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Hepatitis C; Cirrhosis

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Fibrosis
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections

Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 13, 2012