PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370AM2)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00039871

Purpose

The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Condition	Intervention	Phase
Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With 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: Ribavirin Peginterferon Alfa-2b Interferons

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Sustained Virologic Response (SVR) Rate [ Time Frame: Assessed at end of 24 weeks posttreatment follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]
Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]

Enrollment:	2333
Study Start Date:	May 2002
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Overall study population	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks Other Name: SCH 54031 Drug: REBETOL (ribavirin; SCH 18908) REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

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
Positive for Hepatitis C
Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion Criteria:

Any cause for the liver disease other than chronic hepatitis C
History or presence of complications of cirrhosis
Alcohol or illicit drug use or methadone treatment within the past 2 years
Treatment for chronic hepatitis C within the previous 6 months
Diseases or conditions that could interfere with the subject's participation in and completion of the study

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00039871 History of Changes
Other Study ID Numbers:	P02370
Study First Received:	June 13, 2002
Results First Received:	September 29, 2008
Last Updated:	October 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Flaviviridae Infections
Interferon-alpha
Interferons
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012