A Non-interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 538
- 主要终点
- Number of Study Participants Who Had a Virological Response (VR) at Week-72
研究概览
简要总结
The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.
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
- •Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
- •Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
- •Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase [ALT]) levels above the upper normal limit for gender
- •Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
- •A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4
排除标准
- •Known hypersensitivity for any active ingredient or constituent
- •Pregnancy or lactation
- •Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
- •Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
- •Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance <50 mL/minute
- •Hepatitis of immunologic origin or medically documented history of auto-immune disease
- •Severe hepatic disorder or decompensated cirrhosis
- •Pre-existing thyroid disorder, except if under control with classical treatment
- •Epilepsy or central nervous system disorder
- •Hemoglobin pathology, eg, thalassaemia, sickle cell anemia
研究组 & 干预措施
PegIntron Plus Rebetol
Previously untreated patients infected with HCV genotype 1, 4, 5, or 6.
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
PegIntron Plus Rebetol
Previously untreated patients infected with HCV genotype 1, 4, 5, or 6.
干预措施: Rebetol (ribavirin; SCH 18908) (Drug)
结局指标
主要结局
Number of Study Participants Who Had a Virological Response (VR) at Week-72
时间窗: Treatment Week 72
VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond.
次要结局
未报告次要终点