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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




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