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.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00039871

First received: June 13, 2002

Last updated: October 13, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 13, 2002
Last Updated Date	October 13, 2009
Start Date ^ICMJE	May 2002
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 13, 2009)	Sustained Virologic Response (SVR) Rate [ Time Frame: Assessed at end of 24 weeks posttreatment follow-up ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00039871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 13, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370AM2)(COMPLETED)
Official Title ^ICMJE	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)
Brief Summary	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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Overall study population Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2333
Completion Date	September 2007
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00039871
Other Study ID Numbers ^ICMJE	P02370
Has Data Monitoring Committee	Yes
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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