Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys®) and Ribavirin (e.g. Copegus®) With Main Focus Gastroenterologists - a Project in BNG (Association of German Resident Gastroenterologists), Part III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,228
- 主要终点
- Percentage of Participants With Early Virologic Response (EVR)
研究概览
简要总结
This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 years of age or over
- •Clinically diagnosed CHC with detectable virus replication
- •Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.
排除标准
- •Any contraindications for peginterferon alfa-2a or ribavirin treatment
- •Pregnant or breast-feeding
研究组 & 干预措施
Chronic Hepatitis C
Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.
干预措施: Pegylated interferon alfa-2a (Drug)
Chronic Hepatitis C
Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Early Virologic Response (EVR)
时间窗: At Week 12
EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.
Percentage of Participants With End of Treatment (EOT) Response
时间窗: Up to Week 72
EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.
Percentage of Participants With Sustained Virologic Response (SVR)
时间窗: Up to Week 96
SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.
Percentage of Participants With Rapid Virologic Response (RVR)
时间窗: At Week 4
RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.
Percentage of Participants With Serious Adverse Drug Reactions (SADR)
时间窗: Up to Week 96
次要结局
- Percentage Cumulative Dose of Peginterferon Alfa-2a Received(Up to Week 96)
- Percentage Cumulative Dose of Ribavirin Received(Up to Week 96)
- Duration of Peginterferon Alfa-2a Therapy(Up to Week 72)
- Percentage of Participants With the Most Frequent Concomitant Medications(At Baseline (Day 1))