ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (Study P05632AM2)

This study has been terminated.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00856024

First received: March 4, 2009

Last updated: October 14, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 4, 2009
Last Updated Date	October 14, 2011
Start Date ^ICMJE	July 2008
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 14, 2011)	Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks [ Time Frame: First 12 weeks of treatment ] [ Designated as safety issue: No ] The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.
Original Primary Outcome Measures ^ICMJE (submitted: March 4, 2009)	Compliance to treatment in the first 12 weeks [ Time Frame: First 12 weeks of treatment ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00856024 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 14, 2011)	Percent of Participants Who Achieved Rapid Virologic Response (RVR) [ Time Frame: Week 4 ] [ Designated as safety issue: No ] RVR was defined as HCV RNA negative after 4 weeks of treatment. Percent of Participants Who Achieved Early Virologic Response (EVR) [ Time Frame: Week 12 ] [ Designated as safety issue: No ] EVR was defined as HCV RNA negative after 12 weeks of treatment.
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	ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (Study P05632AM2)
Official Title ^ICMJE	ATHENAS - Retrospective Analysis of Compliance to Treatment of Chronic Hepatitis C With Pegylated Interferon Alpha 2b Associated to Ribavirin Until Week 12 and Correlation With Virological Response in Brazil Health Centers
Brief Summary	This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The collection of data for virological response after Week 12 will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.
Detailed Description	This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The physician will be filling out the case report form with the information contained in the medical record. Any dose reduction and/or doses not taken during this period will be reported through the case report form. The collection of data for virological response after Week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Patients will come from approximately 65 Brazilian sites and should satisfy all inclusion criteria and none of the exclusion criteria.
Condition ^ICMJE	Hepatitis C, Chronic
Intervention ^ICMJE	Biological: Peginterferon alfa-2b PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation. Other Name: SCH 54031 Drug: Ribavirin Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation. Other Name: SCH 18908
Study Group/Cohort (s)	Group 1: Naïve patients Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Interventions: Biological: Peginterferon alfa-2b Drug: Ribavirin Group 2: Re-treatment Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Interventions: Biological: Peginterferon alfa-2b Drug: Ribavirin Group 3: HIV/HCV co-infected patients Patients, from Brazil, with confirmed chronic hepatitis C and infected with Humman Immunodeficiency Virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Interventions: Biological: Peginterferon alfa-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	Terminated
Enrollment ^ICMJE	902
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must have confirmed his/her willingness in participating in this study, after having been informed of all aspects that are pertinent to his/her decision to participate, by signing and dating the informed consent form (ICF) approved by the Institutional Review Board / Independent Ethics Committee on Research (IRB/IEC). Adult patients who are 18 years old or above. Must have diagnosis of chronic hepatitis C confirmed through positive qualitative or quantitative PCR (polymerase chain reaction) performed prior to initiation of the patient's treatment. This result shall be documented in the patient's records. Must have completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Patients who started treatment for chronic hepatitis C from the year 2008 or later. Exclusion Criteria: Does not confirm his/her willing in participating in this study or refuses to sign the informed consent form. Did not start the treatment with peginterferon alfa-2b and ribavirin. Patients who have less than 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
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	NCT00856024
Other Study ID Numbers ^ICMJE	P05632, BR 002-07
Has Data Monitoring Committee	No
Responsible Party	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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