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

NCT00856024 | Terminated Results

• 2 other identifiers: P05632BR 002-07
• Study Type: observational
• Target: 902
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks

  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 Outcomes (2)

• Percent of Participants Who Achieved Rapid Virologic Response (RVR)

  Week 4

• Percent of Participants Who Achieved Early Virologic Response (EVR)

  Week 12

Study Arms (3)

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; 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.

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.

Biological: Peginterferon alfa-2b; Drug: Ribavirin

Interventions

Peginterferon alfa-2b BIOLOGICAL

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.

Also known as: SCH 54031

Group 1: Naïve patients; Group 2: Re-treatment; Group 3: HIV/HCV co-infected patients

Ribavirin DRUG

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.

Also known as: SCH 18908

Group 1: Naïve patients; Group 2: Re-treatment; Group 3: HIV/HCV co-infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClincialTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 1, 2015
• Results First Posted: November 28, 2011

Record last verified: 2015-06