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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 902
- 主要终点
- Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Peginterferon alfa-2b (Biological)
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.
干预措施: Ribavirin (Drug)
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.
干预措施: Peginterferon alfa-2b (Biological)
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.
干预措施: Ribavirin (Drug)
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.
干预措施: Peginterferon alfa-2b (Biological)
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.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
时间窗: 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.
次要结局
- Percent of Participants Who Achieved Rapid Virologic Response (RVR)(Week 4)
- Percent of Participants Who Achieved Early Virologic Response (EVR)(Week 12)