NCT01604291已完成不适用
Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 991
- 试验地点
- 21
- 主要终点
- Percentage of Participants With Sustained Viral Response (SVR) at Week 24
研究概览
简要总结
This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.
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
- •Adult patients, >/= 18 years of age
- •Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
- •Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
- •No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
- •Quantitative serum HCV RNA by PCR test before initiation of treatment
排除标准
- •Hepatitis A/B co-infection
- •Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •Pregnant or breast-feeding women
结局指标
主要结局
Percentage of Participants With Sustained Viral Response (SVR) at Week 24
时间窗: Week 24
The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.
次要结局
- Percentage of Participants With Extended RVR(Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group)
- Time to First Dose Modification of Peginterferon Alfa-2a(Week 48)
- Percentage of Participants With End of Treatment Response (EoT)(Week 24)
- Treatment Duration(Week 48)
- Time to First Dose Modification of Ribavirin(Week 48)
- Percentage of Participants Who Had SVR at Week 24 With Dose Modifications(Week 24)
- Comparison of SVR at Week 24(Week 24)
- Percentage of Participants With Rapid Virologic Response (RVR) at Week 4(Week 4)
- Time to First Dose Modification of Telaprevir/Boceprevir(Week 48)
- Number of Participants With SVR at Week 24 According to the Demographic Characteristics(Week 24)
- Percentage of Participants With Complete Early Virologic Response (cEVR)(Week 12)
- Percentage of Participants With Virologic Relapse(Week 72)
- Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia(Week 48)
- Percentage of Participants With Adverse Events (AEs)(Week 48)
- Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia(Week 48)
研究者
研究点 (21)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung CancerNCT05170204Hoffmann-La Roche68
已完成
3 期
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung CancerNon-Small Cell Lung CancerNon-Small Cell Lung CancerNCT06624059Hoffmann-La Roche11
Unknown
不适用
Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab.Diabetes Mellitus, Type 2NCT04326166Dong-A ST Co., Ltd.1,971
已完成
不适用
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis BHepatitis B, ChronicNCT01730508Hoffmann-La Roche978
已完成
不适用
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 InfectionHIV InfectionsNCT01902615Hoffmann-La Roche58