Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00725751

First received: July 25, 2008

Last updated: May 3, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 25, 2008
Last Updated Date	May 3, 2012
Start Date ^ICMJE	September 2007
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 23, 2012)	Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin [ Time Frame: 24 to 48 weeks ] [ Designated as safety issue: No ] For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
Original Primary Outcome Measures ^ICMJE (submitted: July 25, 2008)	Proportions of patients with or without substitution therapy who complete treatment with pegylated interferon and ribavirin for hepatitis C and who achieve sustained virologic response (SVR). [ Time Frame: At the end of treatment and 6 months after the end of treatment with pegylated interferon and ribavirin. ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00725751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 3, 2012)	Number of Participants Who Achieved Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) ] [ Designated as safety issue: No ] SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy [ Time Frame: Day 1 ] [ Designated as safety issue: No ] This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.
Original Secondary Outcome Measures ^ICMJE (submitted: July 25, 2008)	Proportion of patients on substitution therapy within the HCV-infected population who are receiving antiviral treatment. [ Time Frame: At the initiation of treatment with pegylated interferon and ribavirin. ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Official Title ^ICMJE	Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria
Brief Summary	Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.
Condition ^ICMJE	Hepatitis C, Chronic
Intervention ^ICMJE	Biological: Pegylated interferon alfa-2b (PegIFN-2b) PegIFN-2b administered according to European labeling. Other Names: PegIntron SCH 54031 Drug: Ribavirin Ribavirin administered according to European labeling. Other Names: Rebetol SCH 18908
Study Group/Cohort (s)	PegIFN-2b/ribavirin with substitution therapy Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) Interventions: Biological: Pegylated interferon alfa-2b (PegIFN-2b) Drug: Ribavirin PegIFN-2b/ribavirin without substitution therapy Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) Interventions: Biological: Pegylated interferon alfa-2b (PegIFN-2b) Drug: Ribavirin
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	353
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adult patients with hepatitis C Exclusion Criteria: According to the products' European labeling
Gender	Both
Ages	18 Years and older
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	NCT00725751
Other Study ID Numbers ^ICMJE	P05255
Has Data Monitoring Committee	No
Responsible Party	Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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