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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00856024
First received: March 4, 2009
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hepatitis C, Chronic
Biological: Peginterferon alfa-2b
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 902
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 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
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 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
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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00856024     History of Changes
Other Study ID Numbers: P05632, BR 002-07
Study First Received: March 4, 2009
Results First Received: October 14, 2011
Last Updated: July 1, 2014
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014