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

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 (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: PEG-Intron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)	Phase III

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)

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-2b Peginterferon Alfa-2b Interferons

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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

Secondary Outcome Measures:

End-of-Treatment (EOT) Response for Subjects With Missing HCV-RNA Results at Treatment Week 12 [ Time Frame: End of treatment (ie, at Treatment Week 48 or at treatment discontinuation) ] [ Designated as safety issue: No ]
Virologic Response at End of Treatment (EOT) [ Time Frame: Assessed at end of treatment (ie, at Treatment Week 48 or at treatment discontinuation) ] [ Designated as safety issue: No ]
End-of-Treatment (EOT) Response for Subjects With Detectable But <2 Log Drop in HCV-RNA at Treatment Week 12 [ Time Frame: End of treatment (ie, at Treatment Week 48 or at treatment discontinuation) ] [ Designated as safety issue: No ]
Virologic Response at Treatment Week (TW) 12 [ Time Frame: Assessed at Treatment Week 12 ] [ Designated as safety issue: No ]
Sustained Virologic Response (SVR) for Subjects With Detectable But <2 Log Drop in HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]
Sustained Virologic Response (SVR) for Subjects With No Detectable HCV-RNA at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]
Virologic Response at Treatment Week (TW) 24 [ Time Frame: Assessed at Treatment Week 24 ] [ Designated as safety issue: No ]
End-of-Treatment (EOT) Response for Subjects With Detectable But >=2 Log Drop in HCV-RNA at Treatment Week 12 [ Time Frame: End of treatment (ie, at Treatment Week 48 or at treatment discontinuation) ] [ Designated as safety issue: No ]
Sustained Virologic Response (SVR) for Subjects With Missing HCV-RNA Results at Treatment Week 12 [ Time Frame: 24 weeks posttreatment ] [ Designated as safety issue: No ]
End-of-Treatment (EOT) Response for Subjects With No Detectable HCV-RNA at Treatment Week 12 [ Time Frame: End of treatment (ie, at Treatment Week 48 or at treatment discontinuation) ] [ Designated as safety issue: No ]
Sustained Virologic Response (SVR) for Subjects 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
Overall study population: Experimental	Biological: PEG-Intron (peginterferon alfa-2b; SCH 54031) PEG-Intron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg SC QW for up to 48 weeks Drug: REBETOL (ribavirin; SCH 18908) REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day 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:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02370
Study First Received:	June 13, 2002
Results First Received:	September 29, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00039871 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Liver Diseases
Immunologic Factors
Hepatitis, Chronic
Fibrosis
Interferons
Ribavirin
Hepatitis, Viral, Human
Liver Cirrhosis

Angiogenesis Inhibitors
Antiviral Agents
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
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Hepatitis, Chronic
Immunologic Factors
Fibrosis
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Liver Cirrhosis
Pathologic Processes
Therapeutic Uses

Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Interferon-alpha
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C, Chronic
Interferon Alfa-2b

ClinicalTrials.gov processed this record on July 02, 2009