ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632) (ATHENAS)

June 4, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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 Names:
  • 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 Names:
  • SCH 18908
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.
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 Names:
  • 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 Names:
  • SCH 18908
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.
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 Names:
  • 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 Names:
  • SCH 18908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
Time Frame: First 12 weeks of treatment
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.
First 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants Who Achieved Rapid Virologic Response (RVR)
Time Frame: Week 4
RVR was defined as HCV RNA negative after 4 weeks of treatment.
Week 4
Percent of Participants Who Achieved Early Virologic Response (EVR)
Time Frame: Week 12
EVR was defined as HCV RNA negative after 12 weeks of treatment.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05632
  • BR 002-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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