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

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 (submitted: December 10, 2008)	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 ]
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 (submitted: December 10, 2008)	End-of-Treatment (EOT) Response for Subjects With No Detectable HCV-RNA at Treatment Week 12 [ Time Frame: End of treatment ] [ 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 ] 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 ] [ Designated as safety issue: No ] End-of-Treatment (EOT) Response for Subjects With Missing HCV-RNA Results at Treatment Week 12 [ Time Frame: End of treatment ] [ Designated as safety issue: No ] Virologic Response at Treatment Week (TW) 24 [ Time Frame: Assessed at Treatment Week 24 ] [ 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 Missing HCV-RNA Results 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 ] 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 ] [ Designated as safety issue: No ] Virologic Response at End of Treatment (EOT) [ Time Frame: Assessed at end of treatment ] [ Designated as safety issue: No ]

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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis
Intervention ^ICMJE	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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

Administrative Information
NCT ID ^ICMJE	NCT00039871
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P02370
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
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