Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 3
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response (SVR)
研究概览
简要总结
This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic hepatitis C infection
排除标准
- •Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
- •Participants previously treated with pegylated interferon alfa-2a/ribavirin
- •Participation in another clinical study within 30 days prior to study start of ML25544
研究组 & 干预措施
Chronic Hepatitis C
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.
干预措施: Pegylated Interferon Alfa-2a (Drug)
Chronic Hepatitis C
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virological Response (SVR)
时间窗: At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks
SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep \[CAP\]/ COBAS TaqMan \[CTM\] test). Percentage of participants achieving SVR was reported.
PPV of Complete Early Viral Response (cEVR) on SVR
时间窗: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
cEVR was defined as HCV RNA \<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR
时间窗: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
RVR was defined as HCV RNA less than or equal to (\<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
次要结局
- Odds Ratio (OR) for Impact of Age on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Gender on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Baseline Level of Fibrosis (kPa) on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Baseline Viral Load Count on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Overall Duration of Treatment on SVR(Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Body Weight on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Duration of Treatment After Achieving RVR on SVR(Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Duration of Treatment After Achieving cEVR on SVR(Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Cumulative Doses of Ribavirin on SVR(At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks)
- OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR(At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks)