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

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

This study has been completed.

Sponsored by:	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 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 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 C, Chronic Fibrosis Liver Cirrhosis	Drug: Peginterferon alfa-2b Drug: Ribavirin	Phase III

MedlinePlus related topics:

Cirrhosis Hepatitis Hepatitis C

ChemIDplus related topics:

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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)

Further study details as provided by Schering-Plough:

Estimated Enrollment:	2200
Study Start Date:	May 2002
Study Completion Date:	September 2007

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

Study ID Numbers:	P02370
First Received:	June 13, 2002
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00039871
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Interferon-alpha

Liver Diseases

Hepatitis, Chronic

Fibrosis

Interferons

Ribavirin

Hepatitis, Viral, Human

Liver Cirrhosis

Hepatitis

Virus Diseases

Digestive System Diseases

Peginterferon alfa-2b

Hepatitis C

Interferon Alfa-2a

Hepatitis C, Chronic

Interferon Alfa-2b

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Flaviviridae Infections

Therapeutic Uses

Physiological Effects of Drugs

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008