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

Hepatitis C, Chronic Clinical Trial

— ATHENAS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00856024
• Other study ID #: P05632
• Secondary ID: BR 002-07
• Status: Terminated
• Phase: N/A
• First received: March 4, 2009
• Last updated: June 4, 2015
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 902
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percent of Participants Who Achieved Rapid Virologic Response (RVR)	RVR was defined as HCV RNA negative after 4 weeks of treatment.	Week 4	No
Secondary	Percent of Participants Who Achieved Early Virologic Response (EVR)	EVR was defined as HCV RNA negative after 12 weeks of treatment.	Week 12	No