Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 主要终点
- Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
研究概览
简要总结
This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/=18 years and <70 years of age
- •Diagnosis of hepatitis C
- •Assessment of viral load prior to treatment (mandatory for genotype 1 only)
- •Liver biopsy
- •Co-morbidities data
- •Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
- •Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008
排除标准
- •Co-infection with human immunodeficiency virus
- •Co-infection with hepatitis B virus
- •Presence of hepatocarcinoma
- •Patients submitted to hemodialysis
- •Organ transplant patients
研究组 & 干预措施
Conventional Interferon Plus Ribavirin
Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
干预措施: Conventional Interferon (Drug)
Conventional Interferon Plus Ribavirin
Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
干预措施: Ribavirin (Drug)
Peginterferon Alfa-2a Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
干预措施: Peginterferon Alfa-2a (Drug)
Peginterferon Alfa-2a Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
干预措施: Ribavirin (Drug)
Peginterferon Alfa-2b Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
干预措施: Peginterferon Alfa-2b (Drug)
Peginterferon Alfa-2b Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
时间窗: At Week 60
Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \[HCV RNA\] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
次要结局
- Percentage of Participants With Early Virologic Response at Week 12(At Week 12)
- Percentage of Participants With Null Response or No Responder at End of Treatment(At Week 48)
- Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment(At Week 72)
- Percentage of Participants Who Discontinued Treatment Due to Adverse Events(Up to Week 48)
- Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used(At Week 24)
- Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home(At Week 60 (SVR 12) and Week 72 (SVR 24))
- Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders(Up to Week 72)
- Percentage of Participants With Virologic Response at End of Treatment(At Week 48)
- Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment(Up to Week 48)
- Percentage of Participants With Rapid Virologic Response at Week 4(At Week 4)
- Percentage of Participants With Virologic Relapse up to Week 72(Up to Week 72)
- Number of Participants With Any Adverse Events and Any Serious Adverse Events(Up to Week 72)